Healthy VollunteerPhase 1NCT07768176
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PTT-121
A Phase 1 study testing PTT-121 in people with Healthy Vollunteer, run by Pyrotech Therapeutics, Inc. at 1 site in China.
Trial summary
This is a Phase I, single-center, randomized, double-blind, placebo-controlled SAD/MAD study to evaluate safety, tolerability, and PK of Intravenously Administered PTT-121 in healthy Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Vollunteer
- What is being tested?
- PTT-121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 18 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
- Healthy adults aged between 18 and 55 years.
- BMI 18.0-26.0.
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination, etc.
Who cannot join
- History of any clinically significant disease or disorder of the cardiovascular, respiratory, gastrointestinal, genitourinary, hematologic/lymphatic, neurologic, reproductive, psychiatric, endocrine, immunologic, musculoskeletal, breast, ear, ocular, thyroid, neoplastic, metabolic, or dermatologic systems, as determined by the Investigator.
- History of hypersensitivity to the active ingredient of the investigational product, any of its excipients, or related compounds; or a history of severe drug-induced allergic reactions, including but not limited to angioedema and bronchospasm/asthma.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100089
Xue Hong, +86 10 82265573, bysyec@163.comhaiyanli1027@hotmail.com
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PTT-121 After Single and Multiple Ascending Doses in Healthy Chinese Subjects
This is a Phase I, single-center, randomized, double-blind, placebo-controlled SAD/MAD study to evaluate safety, tolerability, and PK of Intravenously Administered PTT-121 in healthy Chinese adults.
- Conditions
- Healthy Vollunteer
- Being tested
- PTT-121, PTT-121 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTT-121Drug
PTT-121 will be administered intravenously
PTT-121 placeboDrug
Matching placebo identical to PTT-121 formulation but without the active pharmaceutical ingredient
| Study group | Role | What they receive |
|---|---|---|
| PTT-121 treatment | Experimental | Not described Receives: Drug: PTT-121 |
| Placebo treatment | Placebo comparator | Not described Receives: Drug: PTT-121 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
Measured: SAD: up to 15 days MAD: up to 21 days
Secondary outcomes (1)
Pharmacokinetics of PTT-121
The drug concentrations of PTT-121will be determined at multiple time points after drug administration.
Measured: SAD: up to 2 days MAD: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start18 Aug 2026
- Primary completion31 Aug 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 VollunteerStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pyrotech Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768176
- Sponsor's protocol ID
- PTT-121-101
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 27 Oct 2026
- Results posted
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PTT-121 After Single and Multiple Ascending Doses in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07768176
- Acronym / sponsor ID
- PTT-121-101
- Conditions
- Healthy Vollunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Pyrotech Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 17 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 Phase I, single-center, randomized, double-blind, placebo-controlled SAD/MAD study to evaluate safety, tolerability, and PK of Intravenously Administered PTT-121 in healthy Chinese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTT-121 treatment | Experimental | Drug: PTT-121 |
| Placebo treatment | Placebo comparator | Drug: PTT-121 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged between 18 and 55 years.
- BMI 18.0-26.0.
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination, etc.
Key exclusion criteria (2 listed)
- History of any clinically significant disease or disorder of the cardiovascular, respiratory, gastrointestinal, genitourinary, hematologic/lymphatic, neurologic, reproductive, psychiatric, endocrine, immunologic, musculoskeletal, breast, ear, ocular, thyroid, neoplastic, metabolic, or dermatologic systems, as determined by the Investigator.
- History of hypersensitivity to the active ingredient of the investigational product, any of its excipients, or related compounds; or a history of severe drug-induced allergic reactions, including but not limited to angioedema and bronchospasm/asthma.
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 |
|---|---|---|
| PTT-121PTT-121 will be administered intravenously | Drug | PTT-121 treatment |
| PTT-121 placeboMatching placebo identical to PTT-121 formulation but without the active pharmaceutical ingredient | Drug | Placebo treatment |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: SAD: up to 15 days MAD: up to 21 days
1 secondary outcome
Pharmacokinetics of PTT-121
Time frame: SAD: up to 2 days MAD: up to 7 days
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 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Vollunteer
Recruiting
Temporal Dynamics of Peripheral SpO₂ During Reoxygenation
Healthy Vollunteer, Apnea
Not yet recruiting
Wearable Sleep EEG and Auditory Stimulation in Healthy Adults
Sleep, Healthy Vollunteer
Not yet recruiting
Effects of Multifidus Lift Exercise on Endurance, Pain, and Disability in University Students With Low Back Pain
Low Back Pain, Non Specific Chronic Low Back Pain
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 PTT-121 in people with Healthy Vollunteer, run by Pyrotech Therapeutics, Inc. 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 3 inclusion and 2 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 27 Oct 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 Ran Wei (+86 10 81938094, ran.wei@pyrotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (time frame: SAD: up to 15 days MAD: up to 21 days). 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 Oct 2026.