Alzheimer s DiseasePhase 1NCT07660341
SAD Study of CGB3002 in Healthy Participants
A Phase 1 study testing CGB3002 0.08 mg/kg, CGB3002 0.4 mg/kg and CGB3002 1.2 mg/kg in people with Alzheimer s Disease, run by ChainGen Biopharma Ltd at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- CGB3002 0.08 mg/kg, CGB3002 0.4 mg/kg and CGB3002 1.2 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
Nucleus Network Melbourne, 1800 243 733, melbourne@nucleusnetwork.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer s Disease
- Being tested
- 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
- Keywords
- CGB3002, Healthy participants, Australia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGB3002 0.08 mg/kgDrug
Cohorts 1: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.08 mg/kg.
CGB3002 0.4 mg/kgDrug
Cohorts 2: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.4 mg/kg.
CGB3002 1.2 mg/kgDrug
Cohorts 3: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 1.2 mg/kg.
CGB3002 3.6 mg/kgDrug
Cohorts 4: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 3.6 mg/kg.
CGB3002 7.2 mg/kgDrug
Cohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg.
PlaceboDrug
Healthy participants will be administered a single intravenous dose of matching placebo.
Comparator DrugDrug
Healthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Cohorts 1-5 each has 2 participants who will receive placebo, 10 in total. Receives: Drug: Placebo |
| Active Comparator | Active comparator | Cohorts 1-5 each has 2 participants will receive active comparator, 10 in total. Receives: Drug: Comparator Drug |
| CGB3002 0.08 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (0.08 mg/kg). Receives: Drug: CGB3002 0.08 mg/kg |
| CGB3002 0.4 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (0.4 mg/kg). Receives: Drug: CGB3002 0.4 mg/kg |
| CGB3002 1.2 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (1.2 mg/kg). Receives: Drug: CGB3002 1.2 mg/kg |
| CGB3002 3.6 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (3.6 mg/kg). Receives: Drug: CGB3002 3.6 mg/kg |
| CGB3002 7.2 mg/kg | Experimental | Healthy participants will be administered a single intravenous dose of CGB3002 (7.2 mg/kg). Receives: Drug: CGB3002 7.2 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to Day 15 weeks.
Secondary outcomes (9)
PK of CGB3002: Maximum Concentration (Cmax)
Cmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Measured: up to 8 weeks
PK of CGB3002: time attain to Cmax (Tmax)
Tmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 8 weeks
PK of CGB3002: the total body clearance (CL)
CL after single intravenous infusion of CGB3002 based on non-compartmental analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start30 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChainGen Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ChainGen Biopharma (Australia) Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Zhizheng Zhang, M.D., Study director, ChainGen Biopharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660341
- Sponsor's protocol ID
- CGB3002-RT01
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07660341
- Acronym / sponsor ID
- CGB3002-RT01
- Conditions
- Alzheimer s Disease
- Keywords
- CGB3002, Healthy participants, Australia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- ChainGen Biopharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- ChainGen Biopharma (Australia) Pty Ltd
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboCohorts 1-5 each has 2 participants who will receive placebo, 10 in total. |
| Active Comparator | Active comparator | Drug: Comparator DrugCohorts 1-5 each has 2 participants will receive active comparator, 10 in total. |
| CGB3002 0.08 mg/kg | Experimental | Drug: CGB3002 0.08 mg/kgHealthy participants will be administered a single intravenous dose of CGB3002 (0.08 mg/kg). |
| CGB3002 0.4 mg/kg | Experimental | Drug: CGB3002 0.4 mg/kgHealthy participants will be administered a single intravenous dose of CGB3002 (0.4 mg/kg). |
| CGB3002 1.2 mg/kg | Experimental | Drug: CGB3002 1.2 mg/kgHealthy participants will be administered a single intravenous dose of CGB3002 (1.2 mg/kg). |
| CGB3002 3.6 mg/kg | Experimental | Drug: CGB3002 3.6 mg/kgHealthy participants will be administered a single intravenous dose of CGB3002 (3.6 mg/kg). |
| CGB3002 7.2 mg/kg | Experimental | Drug: CGB3002 7.2 mg/kgHealthy participants will be administered a single intravenous dose of CGB3002 (7.2 mg/kg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGB3002 0.08 mg/kgCohorts 1: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.08 mg/kg. | Drug | CGB3002 0.08 mg/kg |
| CGB3002 0.4 mg/kgCohorts 2: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.4 mg/kg. | Drug | CGB3002 0.4 mg/kg |
| CGB3002 1.2 mg/kgCohorts 3: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 1.2 mg/kg. | Drug | CGB3002 1.2 mg/kg |
| CGB3002 3.6 mg/kgCohorts 4: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 3.6 mg/kg. | Drug | CGB3002 3.6 mg/kg |
| CGB3002 7.2 mg/kgCohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg. | Drug | CGB3002 7.2 mg/kg |
| PlaceboHealthy participants will be administered a single intravenous dose of matching placebo. | Drug | Placebo |
| Comparator DrugHealthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002. | Drug | Active Comparator |
Primary outcome
Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to Day 15 weeks.
Safety assessment variables will include all adverse events (AEs) including AEs, physical examinations, neurological examinations, vital sign measurements, electrocardiograms, laboratory parameters.
9 secondary outcomes
PK of CGB3002: Maximum Concentration (Cmax)
Time frame: up to 8 weeks
PK of CGB3002: time attain to Cmax (Tmax)
Time frame: up to 8 weeks
PK of CGB3002: Apparent terminal half-life (T1/2)
Time frame: up to 8 weeks
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
PK of CGB3002: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-inf)
Time frame: up to 8 weeks
PK of CGB3002: the total body clearance (CL)
Time frame: up to 8 weeks
PK of CGB3002: Volume of distribution during the terminal phase (Vz)
Time frame: up to 8 weeks
Concentration ratio of CSF to plasma
Time frame: Day 3
Incidence of anti-CGB3002 antibodies (ADAs)
Time frame: up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhizheng Zhang, M.D. study director
ChainGen Biopharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGB3002 0.08 mg/kg, CGB3002 0.4 mg/kg and CGB3002 1.2 mg/kg in people with Alzheimer s Disease, run by ChainGen Biopharma Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ofer Gonen, M.D. ((03) 8593 9801, o.gonen@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: up to Day 15 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.