HealthyPhase 1NCT07126704
A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
A Phase 1 study testing FB-101 in people with Healthy, run by 1ST Biotherapeutics, Inc. at 1 site in South Korea.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration. Up to 72 healthy adult male subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FB-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2027to Mar 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male 19-55 years of age, inclusive, at screening.
- A continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self-reporting.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, clinical laboratory profiles, vital signs, or safety 12-lead ECGs, as deemed by the PI or designee.
- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after (the last) dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to (the first) dosing of the investigational product. A male who has been vasectomized less than 4 months prior to study (first) dosing must follow the same restrictions as a non-vasectomized male).
- Must agree not to donate sperm from the first dosing until 90 days after the last dosing.
- Able to swallow multiple capsules.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- Is at suicidal risk in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
In Jin Jang, M.D. Ph.D, ijjang@snu.ac.kr
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration.
Up to 72 healthy adult male subjects will be enrolled. Additional subjects may be enrolled (8 subjects per cohort) if it is deemed appropriate following review (e.g., in the circumstances where a dose level is repeated, or an intermediate dose is conducted or to add another dose level(s) (higher than those planned)).
- Conditions
- Healthy
- Being tested
- FB-101, Placebo for FB-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB-101Drug
FB-101 10mg
Placebo for FB-101Drug
Placebo for FB-101
| Study group | Role | What they receive |
|---|---|---|
| SAD 1. FB-101 10mg | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| SAD 2. FB-101 20mg | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| SAD 3. FB-101 40mg | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| MAD 4. FB-101 10mg QD | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| MAD 5. FB-101 20mg QD | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| MAD 6. FB-101 30mg QD | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| MAD 7. FB-101 10mg BID | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| MAD 8. FB-101 20mg BID | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
| MAD 9. FB-101 30mg BID | Experimental | Not described Receives: Drug: FB-101; Drug: Placebo for FB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of TEAEs
Number and severity of TEAEs following single ascending oral doses of FB-101 compared to placebo in healthy adult male subjects.
Measured: up to 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1ST Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126704
- Sponsor's protocol ID
- FB101_P102
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07126704
- Acronym / sponsor ID
- FB101_P102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- 1ST Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Aug 2025 (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 Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration.
Up to 72 healthy adult male subjects will be enrolled. Additional subjects may be enrolled (8 subjects per cohort) if it is deemed appropriate following review (e.g., in the circumstances where a dose level is repeated, or an intermediate dose is conducted or to add another dose level(s) (higher than those planned)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SAD 1. FB-101 10mg | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| SAD 2. FB-101 20mg | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| SAD 3. FB-101 40mg | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| MAD 4. FB-101 10mg QD | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| MAD 5. FB-101 20mg QD | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| MAD 6. FB-101 30mg QD | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| MAD 7. FB-101 10mg BID | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| MAD 8. FB-101 20mg BID | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
| MAD 9. FB-101 30mg BID | Experimental | Drug: FB-101, Drug: Placebo for FB-101 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult, male 19-55 years of age, inclusive, at screening.
- A continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self-reporting.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, clinical laboratory profiles, vital signs, or safety 12-lead ECGs, as deemed by the PI or designee.
- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after (the last) dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to (the first) dosing of the investigational product. A male who has been vasectomized less than 4 months prior to study (first) dosing must follow the same restrictions as a non-vasectomized male).
Key exclusion criteria (4 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- Is at suicidal risk in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
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 |
|---|---|---|
| FB-101FB-101 10mg | Drug | MAD 4. FB-101 10mg QD, MAD 5. FB-101 20mg QD, MAD 6. FB-101 30mg QD, MAD 7. FB-101 10mg BID, MAD 8. FB-101 20mg BID, MAD 9. FB-101 30mg BID, SAD 1. FB-101 10mg, SAD 2. FB-101 20mg, SAD 3. FB-101 40mg |
| Placebo for FB-101Placebo for FB-101 | Drug | MAD 4. FB-101 10mg QD, MAD 5. FB-101 20mg QD, MAD 6. FB-101 30mg QD, MAD 7. FB-101 10mg BID, MAD 8. FB-101 20mg BID, MAD 9. FB-101 30mg BID, SAD 1. FB-101 10mg, SAD 2. FB-101 20mg, SAD 3. FB-101 40mg |
Primary outcome
Number and severity of TEAEs
Time frame: up to 2 month
Number and severity of TEAEs following single ascending oral doses of FB-101 compared to placebo in healthy adult male subjects.
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 2 Sep 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 FB-101 in people with Healthy, run by 1ST Biotherapeutics, Inc. at 1 site in South Korea.
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 7 inclusion and 4 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 2 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 South Korea. 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 In Jin Jang, MD, Ph.D. (+8227408290, ijjang@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of TEAEs (time frame: up to 2 month). 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 2 Sep 2026.