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Study of Single IV Administration of P2G12 (FuturePharma)

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ClinicalTrials.gov Identifier: NCT02923999
Recruitment Status : Not yet recruiting
First Posted : October 5, 2016
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:
A randomised phase I trial of a monoclonal antibody which neutralises HIV-1 (P2G12) to be given as a single intravenous infusion to healthy human volunteers to assess the safety and reactogenicity

Condition or disease Intervention/treatment Phase
HIV Infection Drug: P2G12 Dose Cohort 1 Drug: P2G12 Dose Cohort 2 Drug: P2G12 Dose Cohort 3 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase I Dose Escalation Trial to Evaluate Safety and Reactogenicity of Single IV Administration of P2G12
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Dose cohort 1
P2G12 0.125g
Drug: P2G12 Dose Cohort 1
single dose of intravenous infusion: 0.125g of the P2G12 human monoclonal antibody
Other Name: human monoclonal antibody

Experimental: Dose cohort 2
P2G12 0.25g
Drug: P2G12 Dose Cohort 2
single dose of intravenous infusion: 0.25g of the P2G12 human monoclonal antibody
Other Name: human monoclonal antibody

Experimental: Dose cohort 3
P2G12 0.5g
Drug: P2G12 Dose Cohort 3
single dose of intravenous infusion: 0.5g of the P2G12 human monoclonal antibody
Other Name: human monoclonal antibody




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events and serious adverse events assessed by CTCAE v4.0. [ Time Frame: three months ]
  2. Number of participants with local and systemic reactogenicity signs and symptoms post-infusion [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Serum concentration of P2G12 in participants in the active study cohorts [ Time Frame: three months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Volunteers aged between 18 and 45 years on the day of screening
  2. Available for follow-up for the duration of the study
  3. Willing and able to give written informed consent
  4. At low risk of HIV and willing to remain so for the duration of the study defined as:

    1. no history of injecting drug use in the previous ten years
    2. no gonorrhoea or syphilis in the last six months
    3. no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
    4. no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known/presumed to be HIV negative
    5. no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
  5. Willing to undergo a HIV test
  6. If sexually active, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; any IUCD/IUS; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first infusion until 4 months after, and willing to undergo urine pregnancy tests as per schedule
  7. Agree to abstain from donating blood for three months after the end of their participation in the trial, or longer if necessary
  8. Registered with a GP
  9. Satisfactory response received from GP before randomisation

Exclusion Criteria:

  1. Pregnant or lactating
  2. Clinically relevant abnormality on history or examination including

    1. history of grand-mal epilepsy
    2. skin disorder might prevent insertion of IV line
    3. liver disease with inadequate hepatic function (grade 1 or greater as described in appendix 3)
    4. haematological, metabolic, gastrointestinal or cardio-pulmonary disorders
    5. uncontrolled infection; immunodeficiency or use of immunosuppressives in preceding 3 months (including systemic steroids for longer than 14 days)
    6. history of renal disease
    7. history of autoimmune disease
  3. Known hypersensitivity to any component of the infusion used in this trial, or have severe or multiple allergies to drugs or pharmaceutical agents
  4. History of severe local or general reaction to vaccination which according to the investigators judgement might prevent participation
  5. Receipt of blood products or immunoglobulin within 4 months of screening
  6. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
  7. HIV 1/2 positive or indeterminate on screening
  8. Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
  9. A clinically significant amount of protein or blood in the urine
  10. Grade 1 or above routine laboratory parameters (see appendix 3 for definitions). Hyperbilirubinemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
  11. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
  12. Unlikely to comply with protocol or the PI has any concerns about suitability of participation in the study

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): NCT02923999


Contacts
Contact: Catherine Cosgrove 02087252316 ccosgrov@sgul.ac.uk

Locations
United Kingdom
St George's NHS Healthcare Trust Not yet recruiting
London, United Kingdom, SW170RE
Contact: Catherine Cosgrove, PhD MBBS    +44(0)2087252379    ccosgrov@sgul.ac.uk   
Contact: Angela Bartolf         
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Catherine Cosgrove St George's, University of London

Publications of Results:
UNAIDS Fact sheet 2015
WHO Global Health Observatory

Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02923999     History of Changes
Other Study ID Numbers: 14.0231
2016-001817-25 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St George's, University of London:
HIV
MAB
PLANT

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs