Healthy VolunteersPhase 1NCT07679113
IPG1094 Phase I Study for China Healthy Participants
A Phase 1 study testing IPG1094 Tablets in people with Healthy Volunteers, run by Nanjing Immunophage Biotech Co., Ltd at 1 site in China.
Trial summary
This Phase 1 open-label study enrolls 24 healthy Chinese adults to investigate the pharmacokinetics, safety and tolerability of oral IPG1094 tablets. The trial includes two parts. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IPG1094 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jan 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female healthy Chinese participants aged 18 to 50 years (inclusive).
- Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.
- Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) / Height(m)².
- Female participants are non-pregnant and non-lactating.
- Participants have no pregnancy plan and no sperm/egg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.
- Voluntarily sign the written informed consent form, and fully understand the trial content and potential adverse reactions.
Who cannot join
- History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.
- QTcF interval >450 ms (male) or >470 ms (female).
- History of recurrent headache, nausea or vomiting.
- Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.
- History of orthostatic hypotension or dysphagia.
- History of gastrointestinal diseases affecting drug absorption.
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- Lactose intolerance, special dietary restrictions, or unable to follow unified diet requirements during the trial.
- History of drug/food allergy, drug abuse or alcohol abuse.
- Heavy smoking, excessive intake of tea, coffee or caffeinated beverages within 3 months before screening.
- Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening.
- Use of drugs affecting liver metabolism or gastrointestinal environment within 30 days before screening.
- Intake of citrus fruits/juices within 5 days before screening or during the trial.
- Participated in other clinical trials within 3 months before screening.
- Positive result of urine drug screen or breath alcohol test at admission.
- Difficulty in venous blood collection, history of syncope during blood collection.
- Acute illness before screening, or other conditions judged inappropriate for participation by the investigator.
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
Shanghai Xuhui Central Hospital
Shanghai, Xuhui, 200031
Qian Chen, +86-021-54030254, qchen@shxh-centerlab.com
About this study
Official title: A Phase I Clinical Trial Evaluating Pharmacokinetic Characteristics of IPG 1094 in Chinese Healthy Adults
This Phase 1 open-label study enrolls 24 healthy Chinese adults to investigate the pharmacokinetics, safety and tolerability of oral IPG1094 tablets. The trial includes two parts. Part A (12 participants) uses a crossover design to explore the impact of food on a single 200 mg dose of IPG1094; participants will receive the drug under fasting and post-meal conditions on separate days, with intensive blood sampling for PK analysis. Part B (12 participants) evaluates multiple-dose PK, where participants take 200 mg IPG1094 twice daily for 10 days to observe drug exposure and accumulation. All participants will undergo comprehensive safety checks such as lab tests, ECG and adverse event monitoring during screening, treatment and post-dosing follow-up. No placebo or blinding is applied in this study.
- Conditions
- Healthy Volunteers
- Being tested
- IPG1094 Tablets
- Keywords
- Healthy Volunteers，Phase 1, IPG1094, Pharmacokinetics, Safety,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG1094 TabletsDrug
Part A:Oral administration with 240 mL water; fasted: ≥10h overnight fast, no water 1h before/after dosing; fed: take drug within 30 mins of finishing standardized high-fat breakfast. Single dose 200 mg per cycle, two cycles separated by 5-day washout.
Part B:Oral 200 mg twice daily, morning \& evening, continuous 10 days; each dose taken with 240 mL water, restricted water intake 1h pre/post dose; steady-state PK sampling for accumulation assessment.
| Study group | Role | What they receive |
|---|---|---|
| Part A (Single-dose & Food Effect Group) | Experimental | Randomized open-label 2-way crossover single 200 mg IPG1094 tablet, evaluate food effect on PK; 6 subjects fast→fed, 6 subjects fed→fast. Receives: Drug: IPG1094 Tablets |
| Part B (Multiple-dose Group) | Experimental | Open-label multiple-dose IPG1094 200 mg BID oral for 10 consecutive days to assess steady-state PK, safety and tolerability. Receives: Drug: IPG1094 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A:Time to maximum concentration (Tmax)
The time elapsed from IPG1094 administration to the occurrence of Cmax under fasting and high-fat fed states, summarized by median values per treatment sequence.
Measured: Full PK sampling profiles on Day 1 and Day 6
Part A:Plasma maximum concentration (Cmax)
The maximum observed plasma concentration of IPG1094 after a single 200 mg oral dose under fasting and high-fat fed conditions, calculated via non-compartmental analysis (NCA).
Measured: Full PK sampling profiles on Day 1 and Day 6
Part A:Terminal elimination half-life (t1/2)
Description: Terminal elimination half-life of IPG1094 following single-dose administration in fasting and high-fat fed regimens, derived from the terminal log-linear elimination phase of concentration-time curves.
Measured: Serial blood samples collected up to 96 hours post-dose on Day 1 and Day 6
Part B:Steady-state maximum plasma concentration (Css,max)
The maximum observed steady-state plasma concentration of IPG1094 after continuous twice-daily 200 mg dosing for 10 days, calculated via non-compartmental analysis (NCA).
Measured: Full PK sampling profiles on Day 10
Part B:Time to steady-state maximum concentration (Tss,max)
The time elapsed after the Day 10 morning dose to reach steady-state peak concentration (Css,max), presented as descriptive statistics.
Measured: Full PK sampling profiles on Day 10
Part B:Steady-state terminal elimination half-life (t1/2)
Terminal elimination half-life of IPG1094 at steady state after repeated twice-daily dosing, calculated from the log-linear terminal elimination phase of Day 10 concentration-time curve.
Measured: Serial blood samples collected up to 72 hours post-dose on Day 10
Secondary outcomes (1)
Safety indicators：adverse event
Measured: PartA:From signed informed consent through Day 13 follow-up phone call PartB:From signed informed consent through Day 17 follow-up phone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Jul 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 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.
- 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Immunophage Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuhui Central Hospital, Shanghai
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679113
- Sponsor's protocol ID
- IPG1094-HV-C001
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating Pharmacokinetic Characteristics of IPG 1094 in Chinese Healthy Adults
- ClinicalTrials.gov ID
- NCT07679113
- Acronym / sponsor ID
- IPG1094-HV-C001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers，Phase 1, IPG1094, Pharmacokinetics, Safety,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nanjing Immunophage Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xuhui Central Hospital, Shanghai
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 1 Jul 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 Phase 1 open-label study enrolls 24 healthy Chinese adults to investigate the pharmacokinetics, safety and tolerability of oral IPG1094 tablets. The trial includes two parts. Part A (12 participants) uses a crossover design to explore the impact of food on a single 200 mg dose of IPG1094; participants will receive the drug under fasting and post-meal conditions on separate days, with intensive blood sampling for PK analysis. Part B (12 participants) evaluates multiple-dose PK, where participants take 200 mg IPG1094 twice daily for 10 days to observe drug exposure and accumulation. All participants will undergo comprehensive safety checks such as lab tests, ECG and adverse event monitoring during screening, treatment and post-dosing follow-up. No placebo or blinding is applied in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A (Single-dose & Food Effect Group) | Experimental | Drug: IPG1094 TabletsRandomized open-label 2-way crossover single 200 mg IPG1094 tablet, evaluate food effect on PK; 6 subjects fast→fed, 6 subjects fed→fast. |
| Part B (Multiple-dose Group) | Experimental | Drug: IPG1094 TabletsOpen-label multiple-dose IPG1094 200 mg BID oral for 10 consecutive days to assess steady-state PK, safety and tolerability. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female healthy Chinese participants aged 18 to 50 years (inclusive).
- Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.
- Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) / Height(m)².
- Female participants are non-pregnant and non-lactating.
- Participants have no pregnancy plan and no sperm/egg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.
Key exclusion criteria (16 listed)
- History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.
- QTcF interval >450 ms (male) or >470 ms (female).
- History of recurrent headache, nausea or vomiting.
- Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.
- History of orthostatic hypotension or dysphagia.
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 |
|---|---|---|
| IPG1094 TabletsPart A:Oral administration with 240 mL water; fasted: ≥10h overnight fast, no water 1h before/after dosing; fed: take drug within 30 mins of finishing standardized high-fat breakfast. Single dose 200 mg per cycle, two cycles separated by 5-day washout. Part B:Oral 200 mg twice daily, morning \& evening, continuous 10 days; each dose taken with 240 mL water, restricted water intake 1h pre/post dose; steady-state PK sampling for accumulation assessment. | Drug | Part A (Single-dose & Food Effect Group), Part B (Multiple-dose Group) |
Primary outcome
Part A:Time to maximum concentration (Tmax)
Time frame: Full PK sampling profiles on Day 1 and Day 6
The time elapsed from IPG1094 administration to the occurrence of Cmax under fasting and high-fat fed states, summarized by median values per treatment sequence.
Part A:Plasma maximum concentration (Cmax)
Time frame: Full PK sampling profiles on Day 1 and Day 6
The maximum observed plasma concentration of IPG1094 after a single 200 mg oral dose under fasting and high-fat fed conditions, calculated via non-compartmental analysis (NCA).
Part A:Terminal elimination half-life (t1/2)
Time frame: Serial blood samples collected up to 96 hours post-dose on Day 1 and Day 6
Description: Terminal elimination half-life of IPG1094 following single-dose administration in fasting and high-fat fed regimens, derived from the terminal log-linear elimination phase of concentration-time curves.
Part B:Steady-state maximum plasma concentration (Css,max)
Time frame: Full PK sampling profiles on Day 10
The maximum observed steady-state plasma concentration of IPG1094 after continuous twice-daily 200 mg dosing for 10 days, calculated via non-compartmental analysis (NCA).
Part B:Time to steady-state maximum concentration (Tss,max)
Time frame: Full PK sampling profiles on Day 10
The time elapsed after the Day 10 morning dose to reach steady-state peak concentration (Css,max), presented as descriptive statistics.
Part B:Steady-state terminal elimination half-life (t1/2)
Time frame: Serial blood samples collected up to 72 hours post-dose on Day 10
Terminal elimination half-life of IPG1094 at steady state after repeated twice-daily dosing, calculated from the log-linear terminal elimination phase of Day 10 concentration-time curve.
1 secondary outcome
Safety indicators：adverse event
Time frame: PartA:From signed informed consent through Day 13 follow-up phone call PartB:From signed informed consent through Day 17 follow-up phone call
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 10 Aug 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.
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 IPG1094 Tablets in people with Healthy Volunteers, run by Nanjing Immunophage Biotech 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 6 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 10 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. 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 Anzhu Yu (+86-21-34782827, azyu@immunophage.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A:Time to maximum concentration (Tmax) (time frame: Full PK sampling profiles on Day 1 and Day 6). The study lists 6 primary outcomes in all. 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 10 Aug 2026.