Clincosm LogoSign in Get a demo

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

Sponsor
Huahui Health (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05275465
Collaborator
(none)
32
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal antibody in healthy volunteers, and to determine its pharmacokinetic profile and immunogenicity.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a double-blind, placebo-controlled, Phase Ia study aimed to evaluate the safety and tolerability of HH-006 after single ascending doses given as subcutaneous injections.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HH-006

Drug: HH-006
Different dose levels of HH-006
Placebo Comparator: Placebo

Drug: Placebo
Different dose levels of placebo

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment emergent adverse events (TEAEs) [Day 1- Day 113]

    An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.

  2. Severity of treatment emergent adverse events as measured by CTCAE v 5.0 [Day 1- Day 113]

  3. Duration of treatment emergent adverse events [Day 1- Day 113]

Secondary Outcome Measures

  1. Cmax [Day 1-Day 113]

    Maximum observed HH-006 concentration

  2. Tmax [Day 1-Day 113]

    Time to maximum observed HH-006 concentration

  3. AUC0- last [Day 1-Day 113]

    Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration

  4. AUC0-inf [Day 1- Day 113]

    AUC from time zero extrapolated to infinity

  5. t1/2 [Day 1- Day 113]

    Apparent terminal half-life

  6. CL (SAD) [Day 1-Day 113]

    Apparent total body clearance

  7. CL/F (SAD) [Day 1-Day 113]

    Apparent clearance

  8. Vz/F (SAD) [Day 1-Day 113]

    Apparent terminal volume of distribution

  9. Titres of anti drug antibodies (ADA) to HH-006 [Day 1- Day 113]

    To determine the immunogenicity of HH-006

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Generally healthy male or female individuals aged between 18 to 65 years old

  • A bodyweight ≥ 45 kg and the body mass index (BMI) is between 18 to 32 kg/m2.

Exclusion Criteria:

  • History of anaphylaxis or other significant allergy in the opinion of the Investigator or known allergy or hypersensitivity to any of the components of the IP

  • History of drug, alcohol, or substance abuse

  • Any history of liver disease or known hepatic, or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

  • Any history of anaphylaxis, severe allergic reaction, neutralizing antibody generations, or hypersensitivity to albumin or any protein-based therapeutics such as natalizumab (Tysabri) or any other monoclonal antibodies

  • Any previous exposure to chimeric, humanized, or human monoclonal antibody, whether licensed or not

  • Medical history of active infection (acute or chronic)

  • Any safety concern or personal condition that is inappropriate for the study participation per the Investigator's judgement.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Huahui Health

Investigators

  • Principal Investigator: Paul Griffin, Nucleus Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huahui Health
ClinicalTrials.gov Identifier:
NCT05275465
Other Study ID Numbers:
  • HH006-101
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis B

Study Results

No Results Posted as of Mar 11, 2022