Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers

Inclusion Criteria:

1. Signed Informed Consent Form (ICF),

2. Age 18-50 y inclusive at the time of consent,

3. An understanding, ability, and willingness to fully comply with study interventionsand restrictions,

4. Males who are willing to use a condom for contraception during the treatment and for 60 d after IMP administration, or who are convincingly sexually abstinent, or whoare refraining from heterosexual intercourse; females who are willing to use ahighly effective method for contraception during the treatment and for 90 d afterIMP administration, or who are convincingly sexually abstinent, or who arerefraining from heterosexual intercourse, or women not of child-bearing potential (WNOCBP).

5. Satisfactory medical assessment without clinically significant or relevantabnormalities as determined by medical history, physical examination (PE), clinical (vital signs including normal heart rate [50-90 bpm]), laboratory (hematology,biochemistry, urinalysis), and electrocardiographic (ECG) evaluation (corrected QTcinterval within normal range). First degree AV blocks may be acceptable, if thepulse rate complies with the inclusion criteria.

6. Ability to provide written, personally signed and dated informed consent toparticipate in the study, in accordance with the International Conference onHarmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicableregulations, before completing any study-related interventions.

Exclusion Criteria:

1. Current or relevant history of physical or psychiatric illness, any medical disorderthat may require treatment or make the participant unlikely to fully complete thestudy, or any condition that presents undue risk from the IMP or studyinterventions.

2. Any intake of substances (prescription medication, over-the-counter medicine, orherbal preparations with active ingredients) known to inhibit drug-metabolizingenzymes or transport enzymes within a period of less than 5 times the respectiveelimination t1/2 with regard to the expected date of IMP administration (exceptiodine, hormone replacement therapy, hormonal contraception, and levothyroxine).

3. Any intake of substances (prescription medication, over-the-counter medicine, orherbal preparations with active ingredients) known to induce drug-metabolizingenzymes or transport enzymes within a period of 14 d with regard to the expecteddate of IMP administration.

4. A positive result in testing for illegal drugs at screening and enrollment.

5. Male participants who consume more than 21 units of alcohol per week or 3 units perday. Female participants who consume more than 14 units of alcohol per week or 2units per day.

6. Consumption of alcohol within 24 h prior to Day 1 and until End of Study (EOS).

7. Clinically relevant abnormalities regarding ECG conduction (AV block), hematocrit,hemoglobin (Hb), platelets, or leucocytes. A Hb value > 12 g / dl (males) or > 11 g / dl (females) is acceptable.

8. Abnormal renal function as defined by estimated creatinine clearance: < 90 ml / min (Cockcroft-Gault equation).

9. Alanine aminotransferase (ALT) > ULN x 1.1; aspartate aminotransferase (AST) > ULN x 1.2.

10. Thyroid-stimulating hormone (TSH) not within normal limits. If thyroid hormones aresupplemented, reduced TSH values are acceptable, if free thyroxine (T4) and freetriiodothyronine (T3), are within the normal range.

11. Total bilirubin > upper limit of normal (ULN) x 1.2; In case of suspected Gilbert´sdisease: total bilirubin ≤ ULN x 3 is acceptable.

12. Any history of severe allergic or anaphylactic reactions to drugs or food or anyother clinically significant allergies.

13. Known allergy / hypersensitivity to additives used in the IMP.

14. Use of another IMP within 30 d prior to receiving the dose of IMP or activeenrolment in another drug or vaccine clinical trial.

15. A positive human antibody screen for immunodeficiency virus (HIV), or chronichepatitis C virus (HCV), or a positive hepatitis B antigen (HBsAg) test.

16. History of immunization within 14 d prior to expected dosing, including SARS-CoV-2vaccinations, and / or plans to get vaccinated during the observation time

17. Pregnancy or breast feeding

18. Prior exposure in this trial.