SM17 Safety Study

Overseen By Angie Badgett, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: SinoMab BioScience Ltd

Must not be taking: Over-the-counter, Prescription, Herbal, Biologics

Disqualifiers: Diabetes, Cardiac disease, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a new drug, SM17, in healthy individuals. Researchers examine how the body processes and reacts to different doses of SM17, administered through an IV. The trial compares SM17 to a placebo (a substance with no active drug) to better understand its effects. Suitable participants are healthy, non-smoking adults without recent serious infections or chronic diseases. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications to join the trial?

Yes, you will need to stop taking any over-the-counter or prescription medications at least 14 days before the first dose, unless specified otherwise in the protocol. Some exceptions like acetaminophen and hormone replacement therapy are allowed after the first dosing.

Is there any evidence suggesting that SM17 is likely to be safe for humans?

Research has shown that SM17 is generally safe for people. In earlier studies, participants received a single IV dose of up to 1200 mg, while others received three doses of up to 600 mg every two weeks. These doses were well-tolerated, and no serious drug-related side effects were reported. The safety profile of SM17 is positive, indicating it did not cause major health problems in participants. Although this trial is in the early stages, current data suggests that SM17 is safe for humans at the tested doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SM17 because it offers a new approach to treatment through its innovative mechanism of action. Unlike current treatments that may focus on symptom management, SM17 targets the underlying pathways more directly, potentially offering greater efficacy. Additionally, SM17 is administered via peripheral intravenous injection, which could allow for more precise dosing and potentially fewer systemic side effects. This unique combination of targeted action and delivery method sets SM17 apart from existing options and could pave the way for more effective treatments.

What evidence suggests that SM17 might be an effective treatment?

Research has shown that SM17, which participants in this trial may receive, could help treat skin conditions. In earlier studies, SM17 quickly relieved itching and effectively addressed skin problems. Healthy participants tolerated doses up to 1200 mg well, experiencing few side effects. Overall, SM17 seems to work better and more safely than current products for similar conditions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

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, Hysterectomy, Bilateral oophorectomy

Exclusion Criteria

Previously hospitalized for severe acute respiratory syndrome-coronavirus 2 (SARS Cov 2) prior to the screening visit.

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.

Positive polymerase chain reaction test for SARS-CoV-2, either with the absence or presence of the clinical symptoms of COVID 19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose of SM17 or placebo intravenously

0-4 weeks

Treatment Part B

Participants receive multiple ascending doses of SM17 or placebo intravenously

0-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SM17

How Is the Trial Designed?

Group I: Drug SM17 Experimental Treatment 1 Intervention

Peripheral intravenous injection

Group II: Drug Placebo Placebo Group 1 Intervention

Peripheral intravenous injection

Who Is Running the Clinical Trial?

SinoMab BioScience Ltd

Lead Sponsor

Trials

5

Recruited

830+

Published Research Related to This Trial

In a study of 111 individuals with low back pain, patients in the control group were more accurately aware of their treatment assignment compared to those receiving active treatment (78% vs. 54%), indicating that the manual placebo did not effectively blind participants.

Despite the lack of successful blinding, both treatment groups showed significant improvement in pain disability, suggesting that factors beyond the specific biomechanical treatment may contribute to therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments. Hawk, C., Long, CR., Rowell, RM., et al.[2015]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

In a study involving six competitive wheelchair athletes, short-term oral creatine supplementation did not significantly improve 800 m performance compared to a placebo, indicating that creatine may not enhance performance in this specific group.

All measured parameters, including completion time, perceived exertion, lactate levels, and heart rate, showed no significant differences between the creatine and placebo conditions, suggesting that creatine supplementation may not be effective for trained, spinal cord-injured athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of creatine supplementation on 800 m wheelchair performance: a pilot study. Perret, C., Mueller, G., Knecht, H.[2013]

The mouthrinse containing 0.05% CHX and 0.05% CPC significantly reduced plaque levels in patients with poor oral hygiene over a 3-month period, indicating its efficacy in improving oral health (P<0.001).

While the mouthrinse effectively decreased plaque and bleeding on probing, it did not show a significant impact on gingival inflammation or overall patient-reported outcomes, suggesting that while it helps with plaque control, it may not fully address all aspects of gum health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower concentration of chlorhexidine and cetyl-pyridinium chloride mouthwash demonstrates some efficacy. Lamont, T.[2012]

In a study involving 24 rabbits undergoing spine fusion, daily subcutaneous injections of abaloparatide resulted in a 100% fusion rate compared to only 45% in the control group, indicating its strong efficacy in promoting spinal fusion.

Radiographic analysis showed that abaloparatide significantly increased bone formation and quality, with higher bone volume and improved trabecular structure, suggesting it enhances the biological processes necessary for successful spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. Morse, KW., Moore, H., Kumagai, H., et al.[2023]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11663749/

Evaluation of the safety, tolerability, pharmacokinetics and ... A single IV dose of SM17 up to 1200 mg and three Q2W doses up to 600 mg were well tolerated in healthy participants and demonstrated a favorable safety profile.

2. clinicaltrials.gov clinicaltrials.gov/show/NCT05332834

A Phase 1 Study of Single and Multiple Intravenous Doses ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07103369

A Phase I Clinical Study to Evaluate SM17 in Chinese ... It aims to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single and multiple doses of SM17 injection in healthy ...

4. news.futunn.com news.futunn.com/en/post/55215882/the-validation-clinical-data-of-the-sm17-concept-exceeded-expectations

The validation clinical data of the SM17 Concept exceeded ... SM17demonstrates differentiated advantages in rapid itching relief, treatment of skin lesions, and safety compared to existing products on ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39717777/

results from pre-clinical models and a first-in-human, ... A single IV dose of SM17 up to 1200 mg and three Q2W doses up to 600 mg were well tolerated in healthy participants and demonstrated a favorable safety profile.

6. trial.medpath.com trial.medpath.com/news/60f894b58d5699b8/sinomab-s-sm17-shows-breakthrough-results-in-phase-1b-trial-for-atopic-dermatitis

SinoMab's SM17 Shows Breakthrough Results in Phase 1b ... SM17 showed faster onset of anti-pruritus effects (week 2) compared to existing therapies (weeks 4-6), while maintaining a favorable safety ...

7. sinomab.com sinomab.com/pdf/press/20250409_en.pdf

中國抗體製藥有限公司 SinoMab BioScience Limited This study was a 16-week, randomized, placebo-controlled, double-blind study to assess the tolerability, safety and efficacy of SM17 monotherapy ...

8. researchgate.net researchgate.net/publication/387140127_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

results from pre-clinical models and a first-in-human, ... Meanwhile SM17 was well tolerated with no drug-related serious adverse events were observed in the Phase I clinical study (145) . These results ...