Healthy ParticipantsPhase 1NCT06517914
A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
A Phase 1 study testing YH35995 in people with Healthy Participants, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995 Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- YH35995
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2024to Mar 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between the ages of 19 and 45 at the time of providing written consent
- Participants who weigh at least 50 kg at screening and have a body mass index (BMI) of at least 18.0 kg/m2 and less than 30 kg/m2
- Participants who have been fully informed about and fully understand this study, have voluntarily decided to participate, and have agreed in writing to comply with the guidelines of the study during the duration of the study
Who cannot join
- Participation in a bioequivalence trial or any other clinical trials within 6 months prior to the first scheduled dose of the IP (within 1 month of the first scheduled dose for participants who have taken part in a dietary supplement clinical trial)
- Individuals with clinically significant abnormal results that do not match any other inclusion/exclusion criteria, as determined by the principal investigator and the delegated persons(investigator)
- Individuals who are unwilling or unable to comply with the participant guidelines described in this protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Oral Administration of YH35995 in Healthy Adult Male Participants
This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995
Read the detailed description
YH35995 is being developed as a treatment for the neurological symptoms of Gaucher Disease type 3. This study is a first-in-human (FIH), phase 1, randomized, double-blind, placebo-controlled study of YH35995, which consists of two parts. In Part A (SAD), single ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD. In Part B (MAD), multiple ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD.
- Conditions
- Healthy Participants
- Being tested
- YH35995, Placebo
- Keywords
- YH35995, Gaucher Disease
- Medical subject headings
- Gaucher Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH35995Drug
Oral administration of YH35995
PlaceboDrug
Oral administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| YH35995 | Experimental | [Part A] Participants will be orally administered a single dose of YH35995 in five dose groups, gradually escalating from lower to higher doses. Each cohort includes 10 participants (8 randomly assigned to the YH35995 arm and 2 randomly assigned to the placebo arm).
[Part B] Participants will receive multiple oral doses of YH35995 once every 4 weeks in three dose groups. Each cohort includes 12 participants (9 randomly assigned to the YH35995 arm and 3 randomly assigned to the placebo arm). Receives: Drug: YH35995 |
| Placebo | Placebo comparator | [Part A] Participants will be orally administered a single dose of Placebo in five dose groups, gradually escalating from lower to higher doses. Each cohort includes 10 participants (8 randomly assigned to the YH35995 arm and 2 randomly assigned to the placebo arm).
[Part B] Participants will receive multiple oral doses of Placebo once every 4 weeks in three dose groups. Each cohort includes 12 participants (9 randomly assigned to the YH35995 arm and 3 randomly assigned to the placebo arm). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Part A, B] Treatment-emergent adverse events (TEAEs)
To assess the safety and tolerability of a single dose and multiple dose administration of YH35995
Measured: Part A: Day1-150, Part B: Day1-232
Secondary outcomes (22)
[Part A] Maximum observed plasma concentration (Cmax)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part A] Time to reach Cmax (Tmax)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part A] Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part A] AUC from time 0 to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part A] Apparent terminal elimination half-life (t1/2)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part A] Total plasma clearance (CL/F)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part A] Apparent volume of distribution (Vz/F)
To characterize the pharmacokinetics (PK) of YH35995
Measured: Day1-150
[Part B] Cmax during the first dosing interval
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Tmax during the first dosing interval
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] AUC during the first dosing interval (AUCsingle)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] AUC during the dosing interval at steady state (AUCtau,ss)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Cmax at steady state (Cmax,ss)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Tmax at steady state (Tmax,ss)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Accumulation ratio using AUC (Rac(AUC))
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Accumulation ratio using Cmax (Rac(Cmax))
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Plasma concentration at the last observed time point during the dosing interval at steady state (Ctrough)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Average plasma concentration (Cavg)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Clearance at steady state (CLss/F)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Volume of distribution at steady state (Vss)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Effective half-life (t1/2,Rac)
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Cerebrospinal fluid to plasma concentration ratio(C/P ratio) of YH35995
To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration
Measured: Day1-232
[Part B] Properly derived PD parameters for YH35995, including the area under the effect curve (AUEC) and maximum effect (Emax)
To assess the pharmacodynamics (PD) of YH35995 after multiple dose administration
Measured: Day1-232
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start29 Jul 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyounggyoon Yoo, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517914
- Sponsor's protocol ID
- YH35995-101
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to clinicaltrials@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Oral Administration of YH35995 in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT06517914
- Acronym / sponsor ID
- YH35995-101
- Conditions
- Healthy Participants
- Keywords
- YH35995, Gaucher Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Jul 2024 (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 randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995
Detailed description
YH35995 is being developed as a treatment for the neurological symptoms of Gaucher Disease type 3. This study is a first-in-human (FIH), phase 1, randomized, double-blind, placebo-controlled study of YH35995, which consists of two parts. In Part A (SAD), single ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD. In Part B (MAD), multiple ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YH35995 | Experimental | Drug: YH35995[Part A] Participants will be orally administered a single dose of YH35995 in five dose groups, gradually escalating from lower to higher doses. Each cohort includes 10 participants (8 randomly assigned to the YH35995 arm and 2 randomly assigned to the placebo arm). [Part B] Participants will receive multiple oral doses of YH35995 once every 4 weeks in three dose groups. Each cohort includes 12 participants (9 randomly assigned to the YH35995 arm and 3 randomly assigned to the placebo arm). |
| Placebo | Placebo comparator | Drug: Placebo[Part A] Participants will be orally administered a single dose of Placebo in five dose groups, gradually escalating from lower to higher doses. Each cohort includes 10 participants (8 randomly assigned to the YH35995 arm and 2 randomly assigned to the placebo arm). [Part B] Participants will receive multiple oral doses of Placebo once every 4 weeks in three dose groups. Each cohort includes 12 participants (9 randomly assigned to the YH35995 arm and 3 randomly assigned to the placebo arm). |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male between the ages of 19 and 45 at the time of providing written consent
- Participants who weigh at least 50 kg at screening and have a body mass index (BMI) of at least 18.0 kg/m2 and less than 30 kg/m2
- Participants who have been fully informed about and fully understand this study, have voluntarily decided to participate, and have agreed in writing to comply with the guidelines of the study during the duration of the study
Key exclusion criteria (3 listed)
- Participation in a bioequivalence trial or any other clinical trials within 6 months prior to the first scheduled dose of the IP (within 1 month of the first scheduled dose for participants who have taken part in a dietary supplement clinical trial)
- Individuals with clinically significant abnormal results that do not match any other inclusion/exclusion criteria, as determined by the principal investigator and the delegated persons(investigator)
- Individuals who are unwilling or unable to comply with the participant guidelines described in this protocol
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 |
|---|---|---|
| YH35995Oral administration of YH35995 | Drug | YH35995 |
| PlaceboOral administration of Placebo | Drug | Placebo |
Primary outcome
[Part A, B] Treatment-emergent adverse events (TEAEs)
Time frame: Part A: Day1-150, Part B: Day1-232
To assess the safety and tolerability of a single dose and multiple dose administration of YH35995
22 secondary outcomes
[Part A] Maximum observed plasma concentration (Cmax)
Time frame: Day1-150
[Part A] Time to reach Cmax (Tmax)
Time frame: Day1-150
[Part A] Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day1-150
[Part A] AUC from time 0 to infinity (AUCinf)
Time frame: Day1-150
[Part A] Apparent terminal elimination half-life (t1/2)
Time frame: Day1-150
[Part A] Total plasma clearance (CL/F)
Time frame: Day1-150
[Part A] Apparent volume of distribution (Vz/F)
Time frame: Day1-150
[Part B] Cmax during the first dosing interval
Time frame: Day1-232
[Part B] Tmax during the first dosing interval
Time frame: Day1-232
[Part B] AUC during the first dosing interval (AUCsingle)
Time frame: Day1-232
[Part B] AUC during the dosing interval at steady state (AUCtau,ss)
Time frame: Day1-232
[Part B] Cmax at steady state (Cmax,ss)
Time frame: Day1-232
[Part B] Tmax at steady state (Tmax,ss)
Time frame: Day1-232
[Part B] Accumulation ratio using AUC (Rac(AUC))
Time frame: Day1-232
[Part B] Accumulation ratio using Cmax (Rac(Cmax))
Time frame: Day1-232
[Part B] Plasma concentration at the last observed time point during the dosing interval at steady state (Ctrough)
Time frame: Day1-232
[Part B] Average plasma concentration (Cavg)
Time frame: Day1-232
[Part B] Clearance at steady state (CLss/F)
Time frame: Day1-232
[Part B] Volume of distribution at steady state (Vss)
Time frame: Day1-232
[Part B] Effective half-life (t1/2,Rac)
Time frame: Day1-232
[Part B] Cerebrospinal fluid to plasma concentration ratio(C/P ratio) of YH35995
Time frame: Day1-232
[Part B] Properly derived PD parameters for YH35995, including the area under the effect curve (AUEC) and maximum effect (Emax)
Time frame: Day1-232
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to clinicaltrials@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.
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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.
Hyounggyoon Yoo principal investigator
CHA Bundang Medical Center
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 YH35995 in people with Healthy Participants, run by Yuhan Corporation 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 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. 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?
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?
[Part A, B] Treatment-emergent adverse events (TEAEs) (time frame: Part A: Day1-150, Part B: Day1-232). 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 28 Jul 2026.