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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: HTL0022562 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
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.
Drug: HTL0022562
HTL0022562

Drug: Placebo
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.
Drug: HTL0022562
HTL0022562

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04941989


Contacts
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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

Locations
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United Kingdom
Parexel Early Phase Clinical Unit
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Heptares Therapeutics Limited
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Responsible Party: Heptares Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04941989    
Other Study ID Numbers: HTL0022562-101
2020-002887-30 ( EudraCT Number )
246780 ( Other Identifier: Parexel Early Phase Clinical Unit London )
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heptares Therapeutics Limited:
First in Human
Single Ascending Dose
Multiple Ascending Dose