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

H

Huahui Health

Status and phase

Completed
Phase 1

Conditions

Hepatitis B

Treatments

Drug: Placebo
Drug: HH-006

Study type

Interventional

Funder types

Industry

Identifiers

NCT05275465
HH006-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

33 participants in 2 patient groups, including a placebo group

HH-006
Experimental group
Treatment:
Drug: HH-006
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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