Healthy Adult Trial ParticipantsPhase 1NCT07790783
Phase 1 Clinical Study of GenSci164 Injection
A Phase 1 study testing GenSci164 Injection in people with Healthy Adult Trial Participants, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation Phase 1 clinical study to evaluate the safety, tolerability, PK profile, PD profile, and immunogenicity of GenSci164 after a single subcutaneous injection in healthy adult participants in China. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Trial Participants
- What is being tested?
- GenSci164 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2026to 28 Feb 2028
- 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
- Male or female, aged between 18 and 55 years (inclusive) at the time of signing the informed consent form (ICF).
- Body weight ≥ 50 kg for males and ≥ 45 kg for females at screening, and body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
- No clinically significant abnormalities in medical history, physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, etc.), electrocardiogram (ECG), and pulmonary imaging tests, or values outside the normal reference range considered not clinically significant by the investigator during the screening period or before randomization.
- Men and women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures from the screening period to 3 months after the end of the study, and not plan to father a child (for men) or become pregnant (for women) from signing the ICF to 3 months after the end of the study. WOCBP must have a pregnancy test result within the normal range at screening or before randomization, and must not be breastfeeding. Women not of childbearing potential are those who are permanently sterilized (e.g., hysterectomy) or postmenopausal.
- Able to understand the study procedures, voluntarily participate in the study, provide written informed consent, comply with all study requirements, and complete the study.
Who cannot join
- Known allergy to any component of the GenSci164 injection formulation, or a history of severe allergic reactions to any drugs, compounds, foods, or other substances, or a history of allergic diathesis.
- The proposed injection site has tattoos, sunburn, scarring, or other factors that might interfere with the evaluation of the injection site.
- History or presence of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, psychiatric, neurological, respiratory, and/or other significant medical conditions that, in the investigator's opinion, may affect the evaluation of this study.
- Known confirmed history of malignancy.
- Participants with a history of epileptic seizures or an increased risk of epileptic seizures, or participants with a recent history (within 6 months prior to screening) of head trauma resulting in loss of consciousness or concussion.
- History of psychiatric or neurological disorders, or limited ability to perform normal activities, or cognitive impairment.
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- Severe trauma or major surgery within 12 months prior to screening, or gastrointestinal diseases within 3 months prior to screening that could affect the absorption, distribution, metabolism, excretion, or safety evaluation of the IMP.
- Clinically significant abnormal vital signs at screening (and remaining abnormal and clinically significant upon repeat measurement as determined by the investigator), including, but not limited to, systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or < 50 mmHg.
- Positive hepatitis B surface antigen (HBsAg), positive hepatitis C virus antibody (HCV-Ab), preliminary positive human immunodeficiency virus antigen/antibody (HIV Ag/Ab) test, or positive Treponema pallidum antibody (TP-Ab) at screening.
- Clinically significant abnormal findings on chest X-ray.
- As judged by the investigator, participants who are currently using any medications (including over-the-counter [OTC] drugs, herbal, or homeopathic preparations) that cannot be discontinued or avoided from 4 weeks prior to randomization (or the time period defined below) through 1 month after randomization.
- For female participants, use of hormone replacement therapy within 3 months prior to randomization.
- Participation in any clinical trial of an investigational drug (including investigational vaccines) and receipt of the investigational drug within 3 months or within 5 terminal elimination half-lives (whichever is longer) prior to screening; participation in any clinical trial of a medical device within 3 months prior to screening (excluding screening failures); currently participating in other clinical trials.
- Average weekly alcohol consumption exceeding the limit within 6 months prior to randomization [defined as an average weekly intake of > 14 units, where 1 unit of alcohol = 150 mL of wine, or 360 mL of beer, or 45 mL of spirits].
- Average daily smoking of ≥ 5 cigarettes within 6 months prior to randomization, and/or unwillingness to quit smoking during the study, and/or positive nicotine test.
- Positive alcohol breath test, or history of drug abuse, or use of soft drugs (e.g., marijuana) within 3 months prior to screening, or use of hard drugs (e.g., cocaine and ketamine) within 1 year prior to screening, or positive drug screening result [including but not limited to morphine, ketamine, 3,4-methylenedioxyamphetamine, methamphetamine, tetrahydrocannabinol (THC), cocaine].
- Blood donation or blood loss of ≥ 400 mL, or receipt of blood products within 3 months prior to randomization; poor peripheral venous access, or inability to tolerate blood collection due to physical condition.
- Study staff, site personnel, or other persons directly involved in the execution of the protocol.
- Any other medical condition that, in the investigator's opinion, would impair the participant's ability to tolerate the IMP or to continue with the procedures required by this study.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci164 in Healthy Adult Participants in China
This is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation Phase 1 clinical study to evaluate the safety, tolerability, PK profile, PD profile, and immunogenicity of GenSci164 after a single subcutaneous injection in healthy adult participants in China.
- Conditions
- Healthy Adult Trial Participants
- Being tested
- GenSci164 Injection, Placebo
- Keywords
- Healthy Volunteers, GenSci164
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci164 InjectionDrug
6 dose cohorts
PlaceboDrug
6 dose cohorts
| Study group | Role | What they receive |
|---|---|---|
| GenSci164 Injection | Experimental | Not described Receives: Drug: GenSci164 Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) assessed by CTCAE v6.0
Adverse events (AEs)will be identified and collected from physical examination, vital signs, laboratory tests, 12-lead ECG, and other clinical assessments from Day 1 dosing up to 113 days post dose. Severity will be graded per NCI CTCAE v6.0. AEs will be summarized by number and percentage of affected participants, and further categorized by System Organ Class (SOC), Preferred Term (PT), and severity grade.
Measured: From dosing on Day 1 up to 113 days post dose
Secondary outcomes (7)
Area under the concentration-time curve (AUC0-t, AUC0-∞)of "SZ08330849/PEP072 complex, total SZ08330849 antibody, and active PEP072 (free PEP072 and PEP072-albumin conjugate)"
Measured: From dosing on Day 1 up to 113 days post dose
maximum concentration (Cmax)
Measured: From dosing on Day 1 up to 113 days post dose
time to maximum concentration (Tmax)
Measured: From dosing on Day 1 up to 113 days post dose
half-life (t1/2)
Measured: From dosing on Day 1 up to 113 days post dose
Apparent clearance (CL/F)
Measured: From dosing on Day 1 up to 113 days post dose
Apparent volume of distribution (Vz/F)
Measured: From dosing on Day 1 up to 113 days post dose
Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) positivity and ADA titer.
Measured: From dosing on Day 1 up to 113 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion25 Oct 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Trial ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 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
- NCT07790783
- Sponsor's protocol ID
- GenSci164-101
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 27 Aug 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 27 Aug 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 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci164 in Healthy Adult Participants in China
- ClinicalTrials.gov ID
- NCT07790783
- Acronym / sponsor ID
- GenSci164-101
- Conditions
- Healthy Adult Trial Participants
- Keywords
- Healthy Volunteers, GenSci164
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 25 Oct 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 27 Aug 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 single-center, randomized, double-blind, placebo-controlled, single-dose escalation Phase 1 clinical study to evaluate the safety, tolerability, PK profile, PD profile, and immunogenicity of GenSci164 after a single subcutaneous injection in healthy adult participants in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci164 Injection | Experimental | Drug: GenSci164 Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged between 18 and 55 years (inclusive) at the time of signing the informed consent form (ICF).
- Body weight ≥ 50 kg for males and ≥ 45 kg for females at screening, and body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
- No clinically significant abnormalities in medical history, physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, etc.), electrocardiogram (ECG), and pulmonary imaging tests, or values outside the normal reference range considered not clinically significant by the investigator during the screening period or before randomization.
- Men and women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures from the screening period to 3 months after the end of the study, and not plan to father a child (for men) or become pregnant (for women) from signing the ICF to 3 months after the end of the study. WOCBP must have a pregnancy test result within the normal range at screening or before randomization, and must not be breastfeeding. Women not of childbearing potential are those who are permanently sterilized (e.g., hysterectomy) or postmenopausal.
- Able to understand the study procedures, voluntarily participate in the study, provide written informed consent, comply with all study requirements, and complete the study.
Key exclusion criteria (19 listed)
- Known allergy to any component of the GenSci164 injection formulation, or a history of severe allergic reactions to any drugs, compounds, foods, or other substances, or a history of allergic diathesis.
- The proposed injection site has tattoos, sunburn, scarring, or other factors that might interfere with the evaluation of the injection site.
- History or presence of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, psychiatric, neurological, respiratory, and/or other significant medical conditions that, in the investigator's opinion, may affect the evaluation of this study.
- Known confirmed history of malignancy.
- Participants with a history of epileptic seizures or an increased risk of epileptic seizures, or participants with a recent history (within 6 months prior to screening) of head trauma resulting in loss of consciousness or concussion.
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 |
|---|---|---|
| GenSci164 Injection6 dose cohorts | Drug | GenSci164 Injection |
| Placebo6 dose cohorts | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events (AEs) assessed by CTCAE v6.0
Time frame: From dosing on Day 1 up to 113 days post dose
Adverse events (AEs)will be identified and collected from physical examination, vital signs, laboratory tests, 12-lead ECG, and other clinical assessments from Day 1 dosing up to 113 days post dose. Severity will be graded per NCI CTCAE v6.0. AEs will be summarized by number and percentage of affected participants, and further categorized by System Organ Class (SOC), Preferred Term (PT), and severity grade.
7 secondary outcomes
Area under the concentration-time curve (AUC0-t, AUC0-∞)of "SZ08330849/PEP072 complex, total SZ08330849 antibody, and active PEP072 (free PEP072 and PEP072-albumin conjugate)"
Time frame: From dosing on Day 1 up to 113 days post dose
maximum concentration (Cmax)
Time frame: From dosing on Day 1 up to 113 days post dose
time to maximum concentration (Tmax)
Time frame: From dosing on Day 1 up to 113 days post dose
half-life (t1/2)
Time frame: From dosing on Day 1 up to 113 days post dose
Apparent clearance (CL/F)
Time frame: From dosing on Day 1 up to 113 days post dose
Apparent volume of distribution (Vz/F)
Time frame: From dosing on Day 1 up to 113 days post dose
Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) positivity and ADA titer.
Time frame: From dosing on Day 1 up to 113 days post dose
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 27 Aug 2026.
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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.
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 GenSci164 Injection in people with Healthy Adult Trial Participants, 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 19 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: opening soon, as of the sponsor's last update on 27 Aug 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 Qingjiang Ni (+86 17712631723, niqingjiang@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 adverse events (AEs) assessed by CTCAE v6.0 (time frame: From dosing on Day 1 up to 113 days post dose). 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 27 Aug 2026.