AsthmaPhase 1NCT05332834
A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects
A Phase 1 study testing SM17 in people with Asthma, run by SinoMab BioScience Ltd at 1 site in United States.
Trial summary
This trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- SM17
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 26 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female* (of non childbearing potential only), 19-55 years of age, inclusive, at the time of consent.
- Females of non-childbearing potential are defined as follows:
- Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- Hysteroscopic sterilization.
- Bilateral tubal ligation or bilateral salpingectomy.
Show all 16Show fewer
- Hysterectomy.
- Bilateral oophorectomy or
- Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status at the screening visit.
- Male subjects must follow protocol specified contraception guidance as described in Section 12.4.5.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- Is a non-smoker or ex-smoker who has stopped smoking for at least 6 months prior to the screening visit. Ex-smokers will have a history of <10 cigarettes pack-year.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs (12-lead reporting RR, PR, QRS, QT and QTcF), as deemed by the PI or designee, at the screening visit and prior to the first dosing, including the following:
- QTcF interval is ≤460 msec (males) and ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee.
- Must sign an IRB-approved informed consent form (ICF) prior to any study-specific procedures.
- Is able to comply with clinic visits and study-related procedures.
Who cannot join
- Subjects must not be enrolled in the study if they meet any of the following criteria:
- 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 evidence of a clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the PI or designee would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History or current medical conditions, such as myocardial infarction or stroke within the 3 months prior to the screening visit, known cardiac disease, uncontrolled hypertension, and aortic or cerebral aneurysm.
- Previously hospitalized for severe acute respiratory syndrome-coronavirus 2 (SARS Cov 2) prior to the screening visit.
- Positive polymerase chain reaction test for SARS-CoV-2, either with the absence or presence of the clinical symptoms of COVID 19
Show all 30Show fewer
- Has evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 6 weeks prior to the screening visit (e.g., common cold, viral syndrome, flu-like symptoms). Subject who, in the opinion of the PI or designee, has a high risk of parasitic disease is also excluded.
- Has known Type I/II diabetes.
- Was vaccinated with live (attenuated) vaccinations within 1 month prior to the first dosing.
- History of malignancy of any type, (with the exception of successfully treated in situ cervical cancer, or surgically excised non-melanomatous skin cancers) within 5 years prior to the screening visit.
- History of any known primary or secondary immunodeficiency disorder.
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- Positive drugs and/or alcohol results at the screening visit or prior to the first dosing. Subject who has consumed alcohol within 48 hours prior to any study visit including the screening visit, will be excluded.
- History or presence of hypersensitivity or idiosyncratic reaction to protein treatment, medications, any ingredients of SM17 or related compounds.
- Female subjects of childbearing potential.
- Female subject who is lactating or breastfeeding.
- Female subject with a positive pregnancy test at the screening visit.
- Has active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive hepatitis B surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). Subjects with a past or resolved hepatitis B virus infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
- Uses of any over-the-counter or prescription medications (unless otherwise specified in this protocol) within the 14 days or 5 half-lives (whichever is longer), prior to receiving the first dose of SM17. Acetaminophen (up to 2 g per day) for analgesia, hormone replacement therapy (e.g., estrogen, thyroid), and spermicidal agents will be allowed after first dosing. All herbal or traditional Chinese medicines (e.g., St. John's Wort), within the 14 days prior to receiving the first dose of SM17, and continuing use if applicable, will be reviewed by the PI and the Medical Monitor. Written documentation of this review and acknowledgment is required for subject participation.
- Has tattoo(s) or scarring at/or near the site of infusion or any other condition which may interfere with infusion site examination, in the opinion of the PI or designee.
- Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing.
- Donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months of the screening visit; blood donation or loss of blood ≥ 200 mL within 1 month prior to the screening visit; or plan to donate blood during the study period.
- Plasma donation within 7 days prior to the first dosing.
- Donated bone marrow within the last 3 months prior to the first dosing.
- Will not be available for protocol-required study visits or procedures, to the best of the subject and PI or designee's knowledge.
- Has any kind of disorder that, in the opinion of the PI or designee, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
- Is unwilling to avoid rigorous exercise for at least 48 hours prior to first dosing.
- Is unwilling to avoid caffeinated beverages for at least 4 hours prior to first dosing.
- Is receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer) prior to the screening visit. The 30-day window (or 5 half-lives) will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to the screening visit of the current study.
- Is receiving or has received any biologics within 90 days or until the expected PD effect has returned to baseline (whichever is longer) prior to the screening visit. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to the screening visit of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SM17 When Administered Intravenously as a Single Ascending Dose in Healthy Subjects (Part A) and as Multiple Ascending Doses in Healthy Subjects (Part B)
This trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17.
It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single and multiple doses of SM17 injection in healthy subjects.
- Conditions
- Asthma
- Being tested
- SM17, Placebo
- Keywords
- SM17
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM17Biological
Peripheral intravenous injection
PlaceboOther
Peripheral intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Drug SM17 | Experimental | Peripheral intravenous injection Receives: Biological: SM17 |
| Drug Placebo | Placebo comparator | Peripheral intravenous injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and Part B: Number of subjects with adverse events
To evaluate the safety and tolerability of intravenous doses of SM17 in healthy adult subjects.
Measured: Until Follow-up (FU) Visit/Early Termination (ET) Visit (14 and 28 days post-last dose)
Secondary outcomes (1)
Pharmacokinetic parameters of SM17 in healthy subjects
Pharmacokinetic parameters of SM17 in healthy subjects: peak concentration (Cmax)
Measured: 0-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start14 Jun 2022
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Sequential
- Model description
- Biological Product: SM17 monoclonal antibody or Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- SinoMab BioScience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332834
- Sponsor's protocol ID
- SM17-101
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu G, Paglialunga S, Qian X, Ding R, Webster K, van Haarst A, Engel C, Hui CW, Lam LH, Li W, Wu WC, Rasmussen S, Hunt A, Leung SO. Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of SM17 in healthy volunteers: results from pre-clinical models and a first-in-human, randomized, double blinded clinical trial. Front Immunol. 2024 Dec 9;15:1495540. doi: 10.3389/fimmu.2024.1495540. eCollection 2024.
PubMed 39717777
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SM17 When Administered Intravenously as a Single Ascending Dose in Healthy Subjects (Part A) and as Multiple Ascending Doses in Healthy Subjects (Part B)
- ClinicalTrials.gov ID
- NCT05332834
- Acronym / sponsor ID
- SM17-101
- Conditions
- Asthma
- Keywords
- SM17
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- SinoMab BioScience LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 18 Apr 2022 (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 trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17.
It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single and multiple doses of SM17 injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Biological Product: SM17 monoclonal antibody or Placebo
| Arm | Type | Receives |
|---|---|---|
| Drug SM17 | Experimental | Biological: SM17Peripheral intravenous injection |
| Drug Placebo | Placebo comparator | Other: PlaceboPeripheral intravenous injection |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female* (of non childbearing potential only), 19-55 years of age, inclusive, at the time of consent.
- Male subjects must follow protocol specified contraception guidance as described in Section 12.4.5.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- Is a non-smoker or ex-smoker who has stopped smoking for at least 6 months prior to the screening visit. Ex-smokers will have a history of <10 cigarettes pack-year.
Key exclusion criteria (30 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 evidence of a clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the PI or designee would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History or current medical conditions, such as myocardial infarction or stroke within the 3 months prior to the screening visit, known cardiac disease, uncontrolled hypertension, and aortic or cerebral aneurysm.
- Previously hospitalized for severe acute respiratory syndrome-coronavirus 2 (SARS Cov 2) prior to the screening visit.
- Positive polymerase chain reaction test for SARS-CoV-2, either with the absence or presence of the clinical symptoms of COVID 19
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 |
|---|---|---|
| SM17Peripheral intravenous injection | Biological | Drug SM17 |
| PlaceboPeripheral intravenous injection | Other | Drug Placebo |
Primary outcome
Part A and Part B: Number of subjects with adverse events
Time frame: Until Follow-up (FU) Visit/Early Termination (ET) Visit (14 and 28 days post-last dose)
To evaluate the safety and tolerability of intravenous doses of SM17 in healthy adult subjects.
1 secondary outcome
Pharmacokinetic parameters of SM17 in healthy subjects
Time frame: 0-20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 39717777Xu G, Paglialunga S, Qian X, Ding R, Webster K, van Haarst A, Engel C, Hui CW, Lam LH, Li W, Wu WC, Rasmussen S, Hunt A, Leung SO. Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of SM17 in healthy volunteers: results from pre-clinical models and a first-in-human, randomized, double blinded clinical trial. Front Immunol. 2024 Dec 9;15:1495540. doi: 10.3389/fimmu.2024.1495540. eCollection 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 SM17 in people with Asthma, run by SinoMab BioScience Ltd at 1 site in United States.
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 16 inclusion and 30 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: finished, as of the sponsor's last update on 27 Sep 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and Part B: Number of subjects with adverse events (time frame: Until Follow-up (FU) Visit/Early Termination (ET) Visit (14 and 28 days post-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 NCT05332834, which also lists 1 linked publication.
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 Sep 2024.