Healthy ParticipantsPhase 1NCT07510958

A Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation

A Phase 1 study testing SYH2059 in people with Healthy Participants, run by InnovStone Therapeutics Limited.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: SYH2059
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: No sites listed yet
Study dates: 15 Mar 2026to 28 Feb 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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1) Adults aged 18 ~ 55 years (inclusive), male or female;
2) Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m^2 (inclusive);
3) Participant has not engaged in unprotected sexual intercourse within 14 days before screening, and participant and their partner agree to use effective non-hormonal contraception (such as condoms, inert intrauterine devices, female barrier method (cervical cap or diaphragm with spermicide), vaginal contraceptive ring, etc.) or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.) from signing the ICF to 6 months after the end of the study; No sperm donation plan for male participants from signing the ICF to 6 months after the end of the study, and no egg donation plan for female participants from signing the ICF to 6 months after the end of the study;
4) Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written ICF and can comply with the trial procedures.

Who cannot join

1) History of neurological/psychiatric system, respiratory, endocrine, hematological, musculoskeletal, gastrointestinal, and cardiovascular diseases; hepatic and renal diseases, thymic disorders or other diseases that may affect the study results;
2) History of severe drug and food allergies, including allergy to the product or its components; history of herpes zoster infection;
3) Pulmonary ventilation function test showing FEV1 measured value/predicted FEV1 ≤ 80% or FVC ≤ 80% of predicted value, or clinically significant;
4) History of COPD or other respiratory diseases, such as active or inactive tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, overt asthma, positive bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease;
5) Individuals currently suffering from oral lesions or oral ulcers;
6) Individuals engaged in high-risk occupations or fine work (such as high-altitude workers, pilots, etc.);

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7) Participants who have taken any prescription drugs, over-the-counter drugs, Chinese patent medicines, herbal medicines, vitamin dietary supplements, or health products (especially CYP enzyme or transporter inhibitors or inducers) within 4 weeks before randomization; or participants using oral long-acting contraceptives or embedded long-acting contraceptives;
8) Participants with diseases affecting drug absorption, distribution, metabolism and excretion (such as acute and chronic diarrhea, acute and chronic gastritis, gastrectomy, cholecystectomy, intestinal resection, etc., except appendectomy) as judged by the investigator;
9) Participants who cannot receive oral activated charcoal or are allergic to activated charcoal (only 4 mg dose group, tentative);
10) Participants with irregular defecation（only 4 mg dose group, tentative）;
11) Participants who have undergone any surgical operation within 6 months before signing the ICF;
12) Participants with a history of systemic acute infection within 2 weeks before signing the ICF;
13) Participants who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial, or those who plan to participate in strenuous exercise (including body contact sports or collision sports) during the trial;
14) Participants who have received any live vaccine (except influenza vaccine) within 28 days prior to screening or plan to receive vaccination during the study;
15) Participants who have received any investigational drug or participated in any drug clinical trial within 3 months prior to screening, or participated in other medical research activities, and are judged by the investigator to experience discomfort unsuitable for participation in this study;
16) Participants whose physical examination, vital signs measurement, laboratory tests (hematology, urinalysis, stool routine, blood biochemistry, coagulation function, etc.), Chest X-ray (PA \& LAT) and abdominal B-ultrasound examination during the screening are judged by the study doctor to be abnormal and clinically significant ;
17) Participants with clinically significant ECG abnormalities, QTcF interval ≥ 450 ms (male) or ≥ 470 ms (female), complete left bundle branch block, ST-T interval changes indicating myocardial ischemia, second- or third-degree conduction block, severe bradyarrhythmia or tachyarrhythmia, or history of prolonged QTcF interval;
18) Participants who have experienced blood loss or blood donation exceeding 400 mL, received transfusions or use of blood products within 3 months prior to signing the ICF;
19) Participants with special dietary requirements who cannot adhere to the standard study diet;
20) Subjects with a history of needle syncope, motion sickness or those who cannot tolerate intravenous paracentesis for blood collection;
21) Alcoholics: regular drinkers (more than 14 units per week for women and more than 21 units per week for men, such as 360mL beer or 45mL 40% spirits or 150mL wine) in the 6 months prior to signing the ICF, or unable to abstain from alcohol during the study, or a positive alcohol breath test (> 0 mg/100 mL);
22) Smokers: smoking ≥5 cigarettes per day for 6 months before signing the ICF or a positive smoke test result;
23) Habitual intake of excessive xanthine or caffeine-containing foods or beverages, or other foods affecting drug absorption, distribution, metabolism, excretion and other factors within 1 month prior to screening. For example, coffee (more than 1100mL per day), tea (more than 2200 mL per day), cola (more than 2200 mL per day), energy drinks (more than 1100 mL per day), chocolate (more than 510 g per day);
24) Participants with a history of drug abuse/drug use, or those who test positive in drug abuse screening (including benzodiazepine, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinolic acid);
25) Pregnant or breastfeeding women, or those with positive blood pregnancy test result during screening period;
26) Participants with hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV), syphilis-specific antibody (TPPA) and human immunodeficiency virus antigen antibody (Anti-HIV) positive during the screening period;
27) Participants unwilling or unable to correctly use the inhaler to inhale the investigational product according to the inhaler instructions or those who fail in inhaler training;
28) Participants with other factors that, in the opinion of the investigator, are not suitable for participation in the clinical trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation in Healthy Participants

Randomized, double-blind and placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of SYH2059 powder for inhalation after single and multiple doses in healthy subjects. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2059 powder for inhalation. Part 2 is to assess the safety, tolerability and pharmacokinetics of a multiple ascending dose of SYH2059 powder for inhalation.

Conditions: Healthy Participants
Being tested: SYH2059, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYH2059Drug
Inhalation administration
PlaceboDrug
Inhalation administration

Study groups in NCT07510958
Study group	Role	What they receive
SYH2059 SAD experimental group	Experimental	Not described Receives: Drug: SYH2059
Placebo SAD group	Placebo comparator	Not described Receives: Drug: Placebo
SYH2059 MAD experimental group	Experimental	Not described Receives: Drug: SYH2059
Placebo MAD group	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of adverse events (AEs)
Measured: Within 72 hours after the last dose

Secondary outcomes (5)

Area under the concentration-time curve (AUC)
Measured: Within 72 hours after a single dose
Plasma Maximum concentration (Cmax)
Measured: Within 72 hours after a single dose
Half-Life (t1/2)
Measured: Within 72 hours after a single dose
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
Measured: Frame:Within 72 hours after the last dose
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Measured: Within 72 hours after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202628 Feb 2027

First posted6 Apr 2026
Study start15 Mar 2026 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion28 Feb 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
Model description: Drug: SYH2059 Other: Placebo
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07510958
Sponsor's protocol ID: SYH2059-2-001
Status last verified: Feb 2026
First submitted: 29 Mar 2026
Last updated: 6 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Clinical Trials Information Group officer

86-0311-69085587

ctr-contact@cspc.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 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, Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation in Healthy Participants
ClinicalTrials.gov ID: NCT07510958
Acronym / sponsor ID: SYH2059-2-001
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: InnovStone Therapeutics LimitedIndustry (pharma, biotech, devices)
Study start: 15 Mar 2026 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 6 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Drug: SYH2059 Other: Placebo

Arm	Type	Receives
SYH2059 SAD experimental group	Experimental	Drug: SYH2059
Placebo SAD group	Placebo comparator	Drug: Placebo
SYH2059 MAD experimental group	Experimental	Drug: SYH2059
Placebo MAD group	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

1) Adults aged 18 ~ 55 years (inclusive), male or female;
2) Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m^2 (inclusive);
3) Participant has not engaged in unprotected sexual intercourse within 14 days before screening, and participant and their partner agree to use effective non-hormonal contraception (such as condoms, inert intrauterine devices, female barrier method (cervical cap or diaphragm with spermicide), vaginal contraceptive ring, etc.) or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.) from signing the ICF to 6 months after the end of the study; No sperm donation plan for male participants from signing the ICF to 6 months after the end of the study, and no egg donation plan for female participants from signing the ICF to 6 months after the end of the study;
4) Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written ICF and can comply with the trial procedures.

Key exclusion criteria (28 listed)

1) History of neurological/psychiatric system, respiratory, endocrine, hematological, musculoskeletal, gastrointestinal, and cardiovascular diseases; hepatic and renal diseases, thymic disorders or other diseases that may affect the study results;
2) History of severe drug and food allergies, including allergy to the product or its components; history of herpes zoster infection;
3) Pulmonary ventilation function test showing FEV1 measured value/predicted FEV1 ≤ 80% or FVC ≤ 80% of predicted value, or clinically significant;
4) History of COPD or other respiratory diseases, such as active or inactive tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, overt asthma, positive bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease;
5) Individuals currently suffering from oral lesions or oral ulcers;

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
SYH2059Inhalation administration	Drug	SYH2059 MAD experimental group, SYH2059 SAD experimental group
PlaceboInhalation administration	Drug	Placebo MAD group, Placebo SAD group

Primary outcome

The Number of adverse events (AEs)
Time frame: Within 72 hours after the last dose

5 secondary outcomes

Area under the concentration-time curve (AUC)
Time frame: Within 72 hours after a single dose
Plasma Maximum concentration (Cmax)
Time frame: Within 72 hours after a single dose
Half-Life (t1/2)
Time frame: Within 72 hours after a single dose
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
Time frame: Frame:Within 72 hours after the last dose
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Time frame: Within 72 hours after the last dose

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 6 Apr 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.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYH2059 in people with Healthy Participants, run by InnovStone Therapeutics Limited.

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 4 inclusion and 28 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of adverse events (AEs) (time frame: Within 72 hours after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07510958.

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 6 Apr 2026.