Healthy VolunteersPhase 1NCT07476586
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants
A Phase 1 study testing GenSci161 in people with Healthy Volunteers, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GenSci161
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 10 Aug 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).
- Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg/m² (inclusive).
- In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory tests, and imaging examinations, with all results within reference ranges or deemed clinically insignificant by the investigator.
- Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose. From the time of signing the ICF until 6 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female participants must have had no unprotected sexual intercourse within 14 days prior to the first dose.
- Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.
Who cannot join
- History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic diseases.
- Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to screening, or planning to undergo any surgery (including cosmetic procedures) during the trial period.
- Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic [helminth] infections) at any time from 4 weeks prior to screening until the day of randomization.
- Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that may interfere with site assessment.
- History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's judgment, could compromise the trial's conduct. This includes, but is not limited to, disorders of the following systems: neuropsychiatric, cardiovascular, urological, gastrointestinal, respiratory, musculoskeletal, metabolic, endocrine, hematologic, immunologic, and dermatologic, as well as any other major medical conditions and malignancies (with the exception of adequately treated or resected, and resolved non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin).
- A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (TPPA), or hepatitis B virus (HBV) infection (defined as a positive hepatitis B surface antigen [HBsAg] and/or a positive hepatitis B core antibody [HBcAb] result).
- Administration of any live or live-attenuated vaccine within 12 weeks prior to screening or planning to receive any live or live-attenuated vaccine (with the exception of inactivated influenza vaccine) during the trial period.
- Any other condition that, in the judgment of the investigator, would make the participant unsuitable for participation in this 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.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Jing Zhang, Doctor, 021-52887926, Zhangj_fudan@163.com
Guoying Cao, Master, 021-52888195, 13816357099@163.com
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biomarker Characteristics of a Single Subcutaneous Injection of GenSci161 Injection in Healthy Adult Participants
To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
- Conditions
- Healthy Volunteers
- Being tested
- GenSci161, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci161Drug
Administered subcutaneous injection
PlaceboDrug
Administered subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| GenSci0161 | Experimental | Single ascending doses of GenSci161 administered subcutaneous injection Receives: Drug: GenSci161 |
| Placebo | Placebo comparator | All subjects will receive matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures
Measured: Day1- Day183
Secondary outcomes (8)
Area under the concentration-time curve from zero up to a definite time t (AUC0-t)
Measured: Day1- Day183
Area under the concentration-time curve from zero up to infinity (AUC0-∞)
Measured: Day1- Day183
Maximum concentration (Cmax)
Measured: Day1- Day183
Terminal elimination half-life (t1/2)
Measured: Day1- Day183
Apparent clearance (CL/F)
Measured: Day1- Day183
Apparent volume of distribution (Vd/F)
Measured: Day1- Day183
Anti-drug antibody (ADA) and neutralizing antibody(Nab)
Measured: Day1- Day183
Upper limit of the two-sided 90% confidence interval for ∆∆QTcF corresponding to the maximum geometric mean of Cmax obtained from the study
Measured: Day1- Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start20 Apr 2026
- Primary completion6 May 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476586
- Sponsor's protocol ID
- GenSci161-101
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biomarker Characteristics of a Single Subcutaneous Injection of GenSci161 Injection in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07476586
- Acronym / sponsor ID
- GenSci161-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 17 Mar 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.
To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci0161 | Experimental | Drug: GenSci161Single ascending doses of GenSci161 administered subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboAll subjects will receive matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).
- Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg/m² (inclusive).
- In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory tests, and imaging examinations, with all results within reference ranges or deemed clinically insignificant by the investigator.
- Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose. From the time of signing the ICF until 6 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female participants must have had no unprotected sexual intercourse within 14 days prior to the first dose.
- Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.
Key exclusion criteria (8 listed)
- History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic diseases.
- Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to screening, or planning to undergo any surgery (including cosmetic procedures) during the trial period.
- Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic [helminth] infections) at any time from 4 weeks prior to screening until the day of randomization.
- Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that may interfere with site assessment.
- History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's judgment, could compromise the trial's conduct. This includes, but is not limited to, disorders of the following systems: neuropsychiatric, cardiovascular, urological, gastrointestinal, respiratory, musculoskeletal, metabolic, endocrine, hematologic, immunologic, and dermatologic, as well as any other major medical conditions and malignancies (with the exception of adequately treated or resected, and resolved non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin).
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 |
|---|---|---|
| GenSci161Administered subcutaneous injection | Drug | GenSci0161 |
| PlaceboAdministered subcutaneous injection | Drug | Placebo |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures
Time frame: Day1- Day183
8 secondary outcomes
Area under the concentration-time curve from zero up to a definite time t (AUC0-t)
Time frame: Day1- Day183
Area under the concentration-time curve from zero up to infinity (AUC0-∞)
Time frame: Day1- Day183
Maximum concentration (Cmax)
Time frame: Day1- Day183
Terminal elimination half-life (t1/2)
Time frame: Day1- Day183
Apparent clearance (CL/F)
Time frame: Day1- Day183
Apparent volume of distribution (Vd/F)
Time frame: Day1- Day183
Anti-drug antibody (ADA) and neutralizing antibody(Nab)
Time frame: Day1- Day183
Upper limit of the two-sided 90% confidence interval for ∆∆QTcF corresponding to the maximum geometric mean of Cmax obtained from the study
Time frame: Day1- Day15
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 1 May 2026.
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Screening Protocol
Pain
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.
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 GenSci161 in people with Healthy Volunteers, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
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 5 inclusion and 8 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 1 May 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 China. 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 ShuQin Jiang (+86 18036617122, jiangshuqin@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures (time frame: Day1- Day183). 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 1 May 2026.