Safety IssuesPhase 1ETD-001 gelNCT07674862
Safety, Tolerability and Pharmacokinetics of ETD-001 Gel
A Phase 1 study testing Dose 1, dose 2 and dose 3 in people with Safety Issues, run by Etern Therapeutics Wuxi Limited at 1 site in China.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are pre-scheduled for the SAD part. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Dose 1, dose 2 and dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to 30 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -
- Subjects meeting any of the following exclusion criteria will be excluded from this trial:
- Fully understand the purpose, nature and methodology of the trial, as well as potential adverse reactions, and voluntarily sign the informed consent form.
- Healthy male or female Chinese subjects aged between 18 and 60 years inclusive (age determined on the date of signing the informed consent form).
- Body Mass Index (BMI) ranging from 19 to 26 kg/m² inclusive; male subjects shall weigh no less than 50 kg, and female subjects no less than 45 kg.
- No skin rupture, lesions (including skin lesions caused by dermatoses), redness, rash, pigmentation, tattoos, excessive hair or abnormal warmth at the intended application site.
- Subjects are deemed to be in good general health by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry) and viral serology results (all findings are normal or abnormalities are clinically insignificant).
- Female subjects must be non-pregnant and non-lactating. All subjects, regardless of gender, must agree to use medically approved effective contraception from the screening period until 6 months after the last dose. They shall not donate sperm or ova during the study period and within 6 months after the last dose.
Who cannot join
- Subjects who are allergic to the investigational drug or any of its excipients; those with allergic diathesis (e.g., allergy to two or more types of drugs, foods or pollen); or those with severe systemic allergic diseases (e.g., severe asthma, allergic rhinitis, etc.).
- Subjects with clinically significant abnormal medical conditions or factors, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, endocrine, neurological and psychiatric diseases, or other conditions deemed inappropriate for participation in this study by the investigator.
- Subjects who have taken or are expected to take any prescription drugs, over-the-counter medications, vitamin products, health supplements or traditional 4.Chinese medicinal preparations within 14 days prior to the first dose, or within 5 half-lives of the study drug (whichever is longer); or those who have consumed foods or beverages that may induce or inhibit hepatic metabolic enzymes (e.g., grapefruit) within 7 days before dosing.
- Subjects with abnormal liver or renal function:
- Total Bilirubin (TBIL) > 1.5 × ULN;
- AST or ALT ≥ 1.5 × ULN;
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- Blood Urea Nitrogen (BUN) and Creatinine (CRE) > 1.5 × ULN. 5.Subjects with confirmed positive test results for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV) or syphilis at screening.
- 6.Subjects with a history of drug abuse within the past five years, those who have used illicit drugs within 3 months prior to screening, or those with a positive drug abuse screening result at baseline.
- 7.Subjects consuming more than 14 units of alcohol per week within 3 months prior to screening (1 alcohol unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine); those who have consumed alcoholic products within 48 hours before receiving the investigational drug; or those with a positive breath alcohol test at baseline.
- 8.Subjects smoking more than 5 cigarettes per day or habitually using nicotine-containing products within 3 months prior to screening.
- 9.Subjects who have ingested any foods or beverages containing caffeine or xanthine or their metabolites (e.g., coffee, tea, chocolate) within 48 hours prior to the first dose.
- 10.Subjects who have received blood or blood products, or donated/lost more than 400 mL of blood within 3 months prior to the first dose; or those who plan to donate blood during the trial and within 3 months after trial completion.
- 11.Subjects who have participated in another clinical trial and taken other investigational products within 30 days prior to the first dose, or within 5 half-lives of the study drug (whichever is longer).
- 12.Subjects who have suffered from clinically significant severe illnesses or undergone major surgery within 28 days prior to the first dose, or who are expected to receive major surgery during the trial.
- 13.Subjects with difficult venous access or a history of needle phobia or hemophobia.
- 14.Female subjects with a positive pregnancy test at screening or baseline, who are breastfeeding or planning to become pregnant.
- 15.Subjects with a history of chronic skin diseases (e.g., eczema, psoriasis, etc.).
- 16.Any other conditions that, in the investigator's judgment, may prevent the subject from giving informed consent or complying with the trial protocol, or may compromise trial results or the subject's personal safety if the subject participates in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ETD-001 Gel in Healthy Chinese Subjects
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are pre-scheduled for the SAD part. After the safety and tolerability of subjects in the second SAD dose group are confirmed, the MAD part will be initiated upon evaluation by the Safety Review Committee (SRC). Four dose groups are tentatively planned for the MAD part.Each dose group will enroll 8 subjects, who will be randomized at a 6:2 ratio to receive either ETD-001 gel or placebo.
- Conditions
- Safety Issues
- Being tested
- Dose 1, dose 2, dose 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose 1Drug
low dose
dose 2Drug
middle dose
dose 3Drug
high dose
| Study group | Role | What they receive |
|---|---|---|
| ETD-001 gel | Experimental | QD，topical administration Receives: Drug: Dose 1; Drug: dose 2; Drug: dose 3 |
| PLACEBO | Placebo comparator | QD，topical administration Receives: Drug: Dose 1; Drug: dose 2; Drug: dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ETD-001 in healthy Chinese subjects.
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Measured: Up to Day 21
Secondary outcomes (1)
To evaluate the pharmacokinetic characteristics of ETD-001 gel in healthy Chinese subjects.
Area Under Concentration-time [ AUC] of ETD-001cgel
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start16 Mar 2026
- Primary completion5 Jul 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etern Therapeutics Wuxi Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674862
- Sponsor's protocol ID
- ETD-001-101-A
- Acronym
- ETD-001 gel
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 10 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ETD-001 Gel in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07674862
- Acronym / sponsor ID
- ETD-001 gel / ETD-001-101-A
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Etern Therapeutics Wuxi LimitedUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 30 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 single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are pre-scheduled for the SAD part. After the safety and tolerability of subjects in the second SAD dose group are confirmed, the MAD part will be initiated upon evaluation by the Safety Review Committee (SRC). Four dose groups are tentatively planned for the MAD part.Each dose group will enroll 8 subjects, who will be randomized at a 6:2 ratio to receive either ETD-001 gel or placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETD-001 gel | Experimental | Drug: Dose 1, Drug: dose 2, Drug: dose 3QD，topical administration |
| PLACEBO | Placebo comparator | Drug: Dose 1, Drug: dose 2, Drug: dose 3QD，topical administration |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- -
- Subjects meeting any of the following exclusion criteria will be excluded from this trial:
- Fully understand the purpose, nature and methodology of the trial, as well as potential adverse reactions, and voluntarily sign the informed consent form.
- Healthy male or female Chinese subjects aged between 18 and 60 years inclusive (age determined on the date of signing the informed consent form).
- Body Mass Index (BMI) ranging from 19 to 26 kg/m² inclusive; male subjects shall weigh no less than 50 kg, and female subjects no less than 45 kg.
Key exclusion criteria (18 listed)
- Subjects who are allergic to the investigational drug or any of its excipients; those with allergic diathesis (e.g., allergy to two or more types of drugs, foods or pollen); or those with severe systemic allergic diseases (e.g., severe asthma, allergic rhinitis, etc.).
- Subjects with clinically significant abnormal medical conditions or factors, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, endocrine, neurological and psychiatric diseases, or other conditions deemed inappropriate for participation in this study by the investigator.
- Subjects who have taken or are expected to take any prescription drugs, over-the-counter medications, vitamin products, health supplements or traditional 4.Chinese medicinal preparations within 14 days prior to the first dose, or within 5 half-lives of the study drug (whichever is longer); or those who have consumed foods or beverages that may induce or inhibit hepatic metabolic enzymes (e.g., grapefruit) within 7 days before dosing.
- Total Bilirubin (TBIL) > 1.5 × ULN;
- AST or ALT ≥ 1.5 × ULN;
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 |
|---|---|---|
| Dose 1low dose | Drug | ETD-001 gel, PLACEBO |
| dose 2middle dose | Drug | ETD-001 gel, PLACEBO |
| dose 3high dose | Drug | ETD-001 gel, PLACEBO |
Primary outcome
To evaluate the safety and tolerability of ETD-001 in healthy Chinese subjects.
Time frame: Up to Day 21
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
1 secondary outcome
To evaluate the pharmacokinetic characteristics of ETD-001 gel in healthy Chinese subjects.
Time frame: Up to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dose 1, dose 2 and dose 3 in people with Safety Issues, run by Etern Therapeutics Wuxi Limited 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 10 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of ETD-001 in healthy Chinese subjects. (time frame: Up to Day 21). 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 Sep 2026.