SAD Study of CGB3002 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of CGB3002 in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer s Disease
• Intervention / Treatment: Drug: Placebo; Drug: Comparator Drug; Drug: CGB3002 0.08 mg/kg; Drug: CGB3002 0.4 mg/kg; Drug: CGB3002 1.2 mg/kg; Drug: CGB3002 3.6 mg/kg; Drug: CGB3002 7.2 mg/kg

Detailed Description

This study includes 5 planned sequential cohorts. Participants will be randomized to receive a single IV dose of CGB3002, active comparator or placebo, with doses administered in ascending order. Based on the emerging data, there will be options to adjust the number of participants on active or placebo per subsequent dose level, and doses may be repeated or adjusted based on safety, tolerability and plasma pharmacokinetic data. Optional cohorts may be added to evaluate an intermediate dose level or to expand the dose level by SRC.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ofer Gonen, M.D.; Phone Number: (03) 8593 9801; Email: o.gonen@nucleusnetwork.com.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network
      • Contact: Nucleus Network Melbourne; Phone Number: 1800 243 733; Email: melbourne@nucleusnetwork.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• With a history of drug abuse within 12 months prior to dosing.
• Cannot tolerate punction, have a history of needle fainting or blood fainting.
• Have participated in clinical trials, whether for drugs or medical devices, within 30 days prior to administration or within 7 times the known elimination half-life, whichever is longer.
• Blood donation or significant blood loss (> 300 mL) within 30 days prior to dosing, and planning to blood donate during the study.
• Any vaccinations with a live vaccine (excluding influenza vaccine) within 60 days prior to dosing.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥1.5×ULN at screening or Day -2. Total bilirubin (TBIL) > ULN at screening or Day -2(except in those due to findings consistent with Gilbert's disease).
• Estimated creatinine clearance < 80 mL/ min (Cockroft-Gault equation) at screening or Day-2.
• Test positive for syphilis, hepatitis B virus surface antigen (HbsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV-Ab) or HIV antibody at screening.
• Urine drug screening positive at screening or Day-2.
• Have a head MRI demonstrating either cerebral microhemorrhages, or superficial siderosis, or prior evidence of microhemorrhage, or any other major intracranial pathology.
• Still needed or planned to engage in vigorous physical activity or exercise during study participation.
• Other conditions deemed inappropriate by the investigator to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Cohorts 1-5 each has 2 participants who will receive placebo, 10 in total.	Drug: Placebo; Healthy participants will be administered a single intravenous dose of matching placebo.
Active Comparator: Active Comparator; Cohorts 1-5 each has 2 participants will receive active comparator, 10 in total.	Drug: Comparator Drug; Healthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002.
Experimental: CGB3002 0.08 mg/kg; Healthy participants will be administered a single intravenous dose of CGB3002 (0.08 mg/kg).	Drug: CGB3002 0.08 mg/kg; Cohorts 1: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.08 mg/kg.
Experimental: CGB3002 0.4 mg/kg; Healthy participants will be administered a single intravenous dose of CGB3002 (0.4 mg/kg).	Drug: CGB3002 0.4 mg/kg; Cohorts 2: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.4 mg/kg.
Experimental: CGB3002 1.2 mg/kg; Healthy participants will be administered a single intravenous dose of CGB3002 (1.2 mg/kg).	Drug: CGB3002 1.2 mg/kg; Cohorts 3: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 1.2 mg/kg.
Experimental: CGB3002 3.6 mg/kg; Healthy participants will be administered a single intravenous dose of CGB3002 (3.6 mg/kg).	Drug: CGB3002 3.6 mg/kg; Cohorts 4: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 3.6 mg/kg.
Experimental: CGB3002 7.2 mg/kg; Healthy participants will be administered a single intravenous dose of CGB3002 (7.2 mg/kg).	Drug: CGB3002 7.2 mg/kg; Cohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability	Safety assessment variables will include all adverse events (AEs) including AEs, physical examinations, neurological examinations, vital sign measurements, electrocardiograms, laboratory parameters.	up to Day 15 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK of CGB3002: Maximum Concentration (Cmax)	Cmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
PK of CGB3002: time attain to Cmax (Tmax)	Tmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
PK of CGB3002: Apparent terminal half-life (T1/2)	T1/2 after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
PK of CGB3002: Area under the plasma concentration versus time curve from zero to t h post-dose (AUC0-t)	AUC0-t after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
PK of CGB3002: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-inf)	AUC0-inf after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
PK of CGB3002: the total body clearance (CL)	CL after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
PK of CGB3002: Volume of distribution during the terminal phase (Vz)	Vz after single intravenous infusion of CGB3002 based on non-compartmental analysis.	up to 8 weeks
Concentration ratio of CSF to plasma	CSF concentrations were measured by a specific and validated method. Concentration ratio of CSF to plasma on Day 3 post dose will be calculated.	Day 3
Incidence of anti-CGB3002 antibodies (ADAs)	For each dose group, the numbers and proportions of participants who were positive or negative for anti-drug antibodies (ADA) at baseline (baseline prevalence) and after study drug administration (post-baseline incidence during the treatment and follow-up periods) were summarized.	up to 8 weeks

Collaborators and Investigators

• Sponsor: ChainGen Biopharma Ltd
• Collaborators: ChainGen Biopharma (Australia) Pty Ltd
• Investigators: Study Director: Zhizheng Zhang, M.D., ChainGen Biopharma Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Australia; Healthy participants; CGB3002
• Other Study ID Numbers: CGB3002-RT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No