NCT07768176

RecruitingPhase 1

A Study to Evaluate the Safety, Tolerability and Pharmacokin...

Pyrotech Therapeutics, Inc.Source

Pyrotech Therapeutics, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

PTT-121-101

Study Type

interventional

Estimated enrollment

84

Locations

1 country

Sites

1

Timeline

Study Start

August 18, 2026

Actual (reported)

Primary Completion

August 31, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

February 28, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 84 participants
Study completion date: February 28, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 6, 2026
Actual (reported)
First Posted
August 17, 2026
Actual (reported)
Study Start
August 18, 2026
Actual (reported)
Primary Completion
August 31, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 28, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 27, 2026
Status Verified: August 2026
Last Update Submitted: October 21, 2026

Conditions

Healthy Vollunteer

Outcome Measures

Primary Outcomes (1)

Number of Participants With Treatment-emergent Adverse Events
SAD: up to 15 days MAD: up to 21 days

Secondary Outcomes (1)

Pharmacokinetics of PTT-121
SAD: up to 2 days MAD: up to 7 days

Study Arms (2)

PTT-121 treatment

EXPERIMENTAL

Drug: PTT-121

Placebo treatment

PLACEBO COMPARATOR

Drug: PTT-121 placebo

Interventions

PTT-121Drug

PTT-121 will be administered intravenously

PTT-121 treatment

PTT-121 placeboDrug

Matching placebo identical to PTT-121 formulation but without the active pharmaceutical ingredient

Placebo treatment

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Control intervention
PTT-121 placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry record

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy adults aged between 18 and 55 years.
BMI 18.0-26.0.

Sponsors & Collaborators

Pyrotech Therapeutics, Inc.
Industrylead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

Xue HongCONTACT+86 10 82265573 bysyec@163.comhaiyanli1027@hotmail.com

Central Study Contacts

Ran Wei

CONTACT

+86 10 81938094 ran.wei@pyrotech.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 17, 2026

Study Start

August 18, 2026

Actual (reported)

Primary Completion

August 31, 2027

Estimated

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Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination, etc.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

February 28, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

October 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07768176
Data provider: ClinicalTrials.gov
Source updated: 2026-10-27
Normalization version: ctgov-2

Open registry record

Source retrieved: 2026-10-29 23:03:00 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PTT-121 treatment

Placebo treatment

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations