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A Phase 1 Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562

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ClinicalTrials.gov Identifier: NCT04941989
Recruitment Status : Not yet recruiting
First Posted : June 28, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Heptares Therapeutics Limited

Tracking Information
First Submitted Date  ICMJE June 8, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date June 28, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2) ]
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations, local tolerability and site injection reactions, and ECGs will be analyzed in all subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
  • Part 1 and Part 2: Cmax [ Time Frame: Part 1 up to Day 8, Part 2 up to Day 15 ]
    Plasma pharmacokinetic parameter: maximum systemic concentration of HTL0022562
  • Part 1 and Part 2: Tmax [ Time Frame: Part 1 up to Day 8, Part 2 up to Day 15 ]
    Plasma pharmacokinetic parameter: time to Cmax of HTL0022562 Plasma pharmacokinetic parameter: time to Cmax of HTL0022562
  • Part 1 and Part 2: Area Under Curve (AUC) [ Time Frame: Part 1 up to Day 8, Part 2 up to Day 15 ]
    Plasma pharmacokinetic parameter: Area under the plasma concentration versus time curve derived from systemic concentrations of HTL0022562
  • Part 1 and Part 2: Ae [ Time Frame: Part 1 up to Day 8, Part 2 up to Day 15 ]
    Urine pharmacokinetic parameter: Amount of HTL0022562 recovered in urine for each urine collection interval
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562
Official Title  ICMJE A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects
Brief Summary Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.
Detailed Description

This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: HTL0022562
    HTL0022562
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Part 1 Single Ascending Dose
    Eight subjects in up to 7 cohorts will be dosed. One or more subcutaneous injections of HTL0022562 will be administered. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.
    Interventions:
    • Drug: HTL0022562
    • Drug: Placebo
  • Experimental: Part 2 Multiple Ascending Dose
    Eight subjects in up to 4 cohorts will be dosed, following safety, tolerability and PK review of completed dose of Single Ascending Dose Cohort 5. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.
    Interventions:
    • Drug: HTL0022562
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2021)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Healthy males or healthy females (WoNCBP) aged 18 to 55 years inclusive, with a body mass index 18.5-30kgm2 and body weight less than 50kg.
  • Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs and laboratory tests of blood and urine.
  • Willingness to comply with requirements or the trial, including contraception requirements.
  • Able to give fully informed consent.

Key Exclusion Criteria:

  • Confirmed current COVID 19 infection before randomisation.
  • Clinical signs and symptoms consistent with COVID 19 (e.g. fever, dry cough, dyspnoea, sore throat, or fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission.
  • Suffered from severe course of COVID 19 (ECMO, mechanically ventilated).
  • Receipt of any IMP in a clinical research study within the previous 3 months (or 5 half-lives, whichever is longer) of Screening.
  • Any abnormalities on 12-lead ECG or BP at Screening (as specified).
  • History of any drug or alcohol abuse in the past 2 years.
  • Vital signs outside the normal range for healthy volunteers
  • Clinically significant abnormal biochemistry, haematology, coagulation, or urinalysis
  • Abnormal renal function, hepatic function or history of abnormal hepatic function occurring during treatment with investigational or licensed drugs, which led to permanent discontinuation of treatment.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), or human immunodeficiency virus (HIV)
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, or current hepatic renal dysfunction as judged by the investigator.
  • Risk factor for ischaemic heart disease or cerebrovascular disease.
  • Failure to satisfy, in the Investigator's judgement, the subject's fitness to participate for any other reason, including previous serious adverse reaction or serious hypersensitivity reactions to any drug or formulation excipients administered parenterally or orally.
  • All female subjects must have a negative serum and urine pregnancy test at Screening and admission, respectively.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pablo Forte Soto, MD MSc PhD +44 1895 614355 Pablo.ForteSoto@parexel.com
Contact: David Howe, MBChB MD MRCOG +44 1223 949254 David.Howe@soseiheptares.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941989
Other Study ID Numbers  ICMJE HTL0022562-101
2020-002887-30 ( EudraCT Number )
246780 ( Other Identifier: Parexel Early Phase Clinical Unit London )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heptares Therapeutics Limited
Study Sponsor  ICMJE Heptares Therapeutics Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heptares Therapeutics Limited
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP