Health TrialsbyHealthPanel

SAD Study of CGB3002 in Healthy Participants

ConditionAlzheimer s Disease
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CGB3002 0.08 mg/kg

    Drug

    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/kg

    Drug

    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/kg

    Drug

    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/kg

    Drug

    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/kg

    Drug

    Cohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg.

  • Placebo

    Drug

    Healthy participants will be administered a single intravenous dose of matching placebo.

  • Comparator Drug

    Drug

    Healthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002.

Treatment groups

46 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: PlaceboPlacebo comparator 1 intervention
Group B: Active ComparatorActive comparator 1 intervention
Group C: CGB3002 0.08 mg/kgExperimental treatment 1 intervention
Group D: CGB3002 0.4 mg/kgExperimental treatment 1 intervention
Group E: CGB3002 1.2 mg/kgExperimental treatment 1 intervention
Group F: CGB3002 3.6 mg/kgExperimental treatment 1 intervention
Group G: CGB3002 7.2 mg/kgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to Day 15 weeks.

Secondary outcomes

1

PK of CGB3002: Maximum Concentration (Cmax)

Cmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.

Time frame
up to 8 weeks
2

PK of CGB3002: time attain to Cmax (Tmax)

Tmax after single intravenous infusion of CGB3002 based on non-compartmental analysis.

Time frame
up to 8 weeks
3

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

T1/2 after single intravenous infusion of CGB3002 based on non-compartmental analysis.

Time frame
up to 8 weeks
4

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.

Time frame
up to 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ChainGen Biopharma Ltd

Lead sponsor

ChainGen Biopharma (Australia) Pty Ltd

Collaborator

Source ClinicalTrials.gov
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