RecruitingPhase 1

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

Lead sponsor

ChainGen Biopharma Ltd

Asset

CGB3002

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Healthy volunteers•Brain MRI excludes superficial siderosis

Primary endpoint

•Adverse Events as a Measure of Safety and Tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCGB3002-RT01

NCT IDNCT07660341

Timeline

Milestones

Study first posted2026-06-22actual

Study start2026-06-30actual

Last update posted2026-07-08actual

Primary completion2027-04-30estimated

Study completion2027-04-30estimated

Assets

Drug assets

CGB3002

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Concentration ratio of CSF to plasma

Time frame:Day 3

concentration, descriptive

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:up to Day 15 weeks.

threshold achievement, event

Secondary/protocol endpoint

PK of CGB3002: Maximum Concentration (Cmax)

Time frame:up to 8 weeks

concentration, descriptive

Secondary/protocol endpoint

PK of CGB3002: time attain to Cmax (Tmax)

Time frame:up to 8 weeks

concentration, descriptive

Secondary/protocol endpoint

PK of CGB3002: Apparent terminal half-life (T1/2)

Time frame:up to 8 weeks

concentration, descriptive

Secondary/protocol endpoint

PK of CGB3002: Area under the plasma concentration versus time curve from zero to t h post-dose (AUC0-t)

Time frame:up to 8 weeks

concentration, descriptive

Secondary/protocol endpoint

PK of CGB3002: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-inf)

Time frame:up to 8 weeks

concentration, descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

PK of CGB3002: the total body clearance (CL)

Time frame:up to 8 weeks

descriptive

Secondary/protocol endpoint/low confidence

PK of CGB3002: Volume of distribution during the terminal phase (Vz)

Time frame:up to 8 weeks

descriptive

Secondary/protocol endpoint/low confidence

Incidence of anti-CGB3002 antibodies (ADAs)

Time frame:up to 8 weeks

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.