SAD Study of CGB3002 in Healthy Participants
ConditionAlzheimer s Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorChainGen Biopharma Ltd
About this trial
This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single ascending IV doses of CGB3002 in healthy participants. CGB3002 is being developed to treat Alzheimer's Disease.
Eligibility criteria
Qualifiers
Must have signed written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Age≥18 years and<55 years at the time of consent, healthy participants, male or female.
A body mass index (BMI) of 18 to 32 kg/m2 (cutoff inclusive), with male participants weighing no less than 50 kg, female participants weighing no less than 40 kg.
Males and females of childbearing potential agree to have no plans for childbearing, use reliable contraceptive measures and not to donate sperm or ova from 30 days prior to dosing until 120 days after dosing. For females of childbearing potential, hormonal contraceptives should begin at least 1 month prior to screening to ensure contraceptive is in full effect.
Disqualifiers
A known history of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis) or a known history of allergy to biologics or any excipients in biologics, fully resolved childhood asthma can be enrolled.
Any disease that may affect the safety evaluation of the participants or the in vivo process of the investigational product, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematopoietic system, metabolic endocrine system, etc.
Use of prescription drugs within 14 days or five half-lives (whichever is longer) prior study drug administration, unless determined by the Investigator and Sponsor to be non-interfering (e.g., hormonal contraceptives).
Use of over-the-counter (OTC) or Chinese herbal medicine within 7 days or 5 half-lives (whichever is longer) prior to study drug administration, unless determined by the Investigator and Sponsor to be non-interfering.
Trial design
Treatments tested in this trial
- CGB3002 0.08 mg/kg
- CGB3002 0.4 mg/kg
- CGB3002 1.2 mg/kg
- CGB3002 3.6 mg/kg
- CGB3002 7.2 mg/kg
- Placebo
- Comparator Drug
Treatment groups
46 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
ChainGen Biopharma Ltd
Lead sponsor
ChainGen Biopharma (Australia) Pty Ltd
Collaborator
Source ClinicalTrials.gov